Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 15 de 15
Filter
1.
J Gynecol Obstet Hum Reprod ; 53(9): 102832, 2024 Aug 02.
Article in English | MEDLINE | ID: mdl-39098583

ABSTRACT

BACKGROUND: Previous studies have highlighted patients with chronic conditions seek for medical knowledge and therapeutics on their own. So far, no data exist on the health literacy of patients with gynecological conditions and especially those suffering from endometriosis, whose symptoms' have a major impact on their daily lives. METHOD: The objective was to evaluate the health literacy of patients consulting in a referral expert center for the management of endometriosis and gynecological cancers. The secondary objective was to compare the health literacy of patients with endometriosis to patients without. We conducted an observational, prospective, monocentric study in the gynecological department of Tenon Hospital (Paris, France) between July 6, 2022 to January 3, 2023. All patients fulfilled the validated French version of HLS-EU-Q16 questionnaire. RESULTS: One hundred and ten patients were included. The two following questions were identified as the most difficult among patients with endometriosis: "Find information about treatments for their disease" and "know when it would be helpful to have another doctor's opinion". Compared to patients consulting for other conditions, it was more difficult for patients with endometriosis to respectively "find information about treatments for diseases" and "use information given by the doctor to take decisions about the illness" (p = 0.003). Compared to patients consulting for cancer, it was more difficult for patient with endometriosis to "find information about treatments for diseases" (p = 0.02). CONCLUSION: Progresses in the capacity of the health care to better inform the patients would be highly beneficial, especially for those suffering from endometriosis.

2.
Article in English | MEDLINE | ID: mdl-38901689

ABSTRACT

OBJECTIVE: Despite various surgical and non-surgical strategies for abdominal wall endometriosis, the lack of definitive guidance on optimal treatment choice leads to clinical uncertainty. This review scrutinizes the safety and efficacy of abdominal wall endometriosis treatments to aid in decision-making. DATA SOURCES: We performed a systematic literature review of PubMed, Embase and Cochrane Library databases from 1947 until December 2023. METHODS OF STUDY SELECTION: A comprehensive literature search identified studies that assessed both surgical and nonsurgical interventions, including high-intensity focused ultrasound (HIFU), cryoablation, radiofrequency ablation (RFA), and microwave ablation (MWA). This review is registered in NIHR-PROSPERO (CRD 42023494969). Local tumor control (LTC), local pain relief (LPR) and adverse events (AE) were recorded. TABULATION, INTEGRATION, AND RESULTS: This review included 51 articles among 831 identified. All study designs were considered eligible for inclusion. A total of 2,674 patients are included: 2,219 patients (83%) undergoing surgery, and 455 (17%) undergoing percutaneous interventions (342 HIFU, 103 cryoablation, 1 RFA, 9 MWA). Follow-up length was 18 months in median, ranging from 1 to 235 months. Overall LTC rates ranged from 86% to 100%. Surgical interventions consistently demonstrated the highest rate of LTC with a median rate of 100%, and LPR with a median rate of 98.2% (95% confidence interval [CI]: 93.9-97.7). HIFU showed median LTC and LPR rates, respectively of 95.65% (95% CI, 87.7-99.9) and 76.1% (95% CI, 61.8-90.4); and cryoablation of 85.7% (95% CI, 66.0-99.9) and 79.2% (95% CI, 67.4-91.03). Minor AE were reported after surgery in 17.5% of patients (225/1284) including 15.9% (199/1284) of mesh implantation; 76.4% (239/313) after HIFU; and 8.7 % (9/103) after cryoablation. Severe AE were reported in 25 patients in the surgery group and 1 in the percutaneous group. CONCLUSION: The safety profile and efficacy of nonsurgical interventions support their clinical utility for management of abdominal wall endometriosis.

3.
Eur J Obstet Gynecol Reprod Biol ; 297: 227-232, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38691975

ABSTRACT

AIM: To assess the benefit of prophylactic abdominal drainage (AD) after colorectal surgery for endometriosis. METHODS: We conducted a retrospective study of 215 patients who underwent colorectal surgery for endometriosis using a mini-invasive approach in our center from February 2019 to July 2023. A propensity score matched (PSM) analysis (1:1 ratio) identified two groups of patients with similar characteristics. Postoperative outcomes were then compared. RESULTS: In the unmatched cohort, 151 patients (70 %) had AD at the end of surgery and 64 (30 %) did not. Clinical characteristics and surgical procedures were comparable between the groups after PSM. After PSM, AD was associated with a longer hospital stay (p < 0.001) and a greater number of postoperative complications (p = 0.03). There were no differences for readmission, repeat surgery, or severe postoperative complications. CONCLUSION: In this retrospective cohort of patients undergoing colorectal resection for endometriosis using a mini-invasive approach, prophylactic AD was not found to be beneficial.


Subject(s)
Drainage , Endometriosis , Postoperative Complications , Propensity Score , Humans , Female , Endometriosis/surgery , Retrospective Studies , Adult , Drainage/methods , Postoperative Complications/prevention & control , Postoperative Complications/etiology , Postoperative Complications/epidemiology , Length of Stay/statistics & numerical data
4.
Eur J Obstet Gynecol Reprod Biol ; 297: 187-196, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38677096

ABSTRACT

OBJECTIVE: Patients with superficial peritoneal endometriosis (SPE) present with symptoms suggestive of endometriosis but clinical and imaging exams are inconclusive. Consequently, laparoscopy is usually necessary to confirm diagnosis. The present study aimed to evaluate the accuracy of microRNAs (miRNAs) to diagnose patients with SPE from the ENDOmiARN cohort STUDY DESIGN: This prospective study (NCT04728152) included 200 saliva samples obtained between January and June 2021 from women with pelvic pain suggestive of endometriosis. All patients underwent either laparoscopy and/or MRI to confirm the presence of endometriosis. Among the patients with endometriosis, two groups were defined: an SPE phenotype group of patients with peritoneal lesions only, and a non-SPE control group of patients with other endometriosis phenotypes (endometrioma and/or deep endometriosis). Data analysis consisted of two parts: (i) identification of a set of miRNA biomarkers using next-generation sequencing (NGS), and (ii) development of a saliva-based miRNA signature for the SPE phenotype in patients with endometriosis based on a Random Forest (RF) model. RESULTS: Among the 153 patients with confirmed endometriosis, 10.5 % (n = 16) had an SPE phenotype. Of the 2633 known miRNAs, the feature selection method generated a signature of 89 miRNAs of the SPE phenotype. After validation, the best model, representing the most accurate signature had a 100 % sensitivity, specificity, and AUC. CONCLUSION: This signature could constitute a new diagnostic strategy to detect the SPE phenotype based on a simple biological test and render diagnostic laparoscopy obsolete. PRéCIS: We generated a saliva-based signature to identify patients with superficial peritoneal endometriosis which is the most challenging form of endometriosis to diagnose and which is often either misdiagnosed or requires invasive laparoscopy.


Subject(s)
Endometriosis , MicroRNAs , Phenotype , Saliva , Humans , Female , Endometriosis/diagnosis , Endometriosis/genetics , Adult , MicroRNAs/metabolism , MicroRNAs/analysis , MicroRNAs/genetics , Saliva/chemistry , Prospective Studies , Peritoneal Diseases/diagnosis , Peritoneal Diseases/genetics , Peritoneal Diseases/metabolism , Biomarkers/metabolism , Biomarkers/analysis , Sensitivity and Specificity
6.
Eur J Surg Oncol ; 50(6): 108281, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38642512

ABSTRACT

INTRODUCTION: Cervical cancer is a global public health concern. Despite ESGO recommendations and FIGO classification changes, management of locally advanced cervical cancer (LACC) remains debated in France. Our study aimed to review LACC treatment practices and assess adherence to ESGO recommendations among different practitioners. METHODS: From February 2021 to August 2022, we conducted a survey among gynecologic oncology surgeons, radiation oncologists, and medical oncologists practicing in France and managing LACC (FIGO stages IB3-IVA) according to the 2018 FIGO classification. We analyzed responses against the 2018 ESGO recommendations as a "gold standard." RESULTS: Among 115 respondents (56% radiation oncologists, 30% surgeons, 13% medical oncologists), 48.6% of gynecologic surgeons didn't perform para-aortic lymphadenectomy (PAL) with significant radiologic pelvic involvement. PAL, when indicated by PET-CT, was more common in university hospitals (66.7% of surgeons). Surgeons in university hospitals also followed ESGO recommendations more closely. Overall, compliance with all ESGO recommendations was low: 5.7% of surgeons, 21.5% of radiation oncologists, and 60% of medical oncologists. Prophylactic para-aortic irradiation, per ESGO, was more frequent in comprehensive cancer centers (52% of radiation oncologists). CONCLUSION: Adherence to ESGO recommendations for LACC treatment appears low in France, particularly in surgery, with limited PAL in cases of lymph node negativity on PET-CT. However, these recommendations are more often followed by surgeons in university hospitals and radiation oncologists in cancer centers. Adherence to these recommendations may impact patient survival and warrants evaluation of care quality, justifying the organization of LACC management in expert centers.


Subject(s)
Guideline Adherence , Lymph Node Excision , Practice Patterns, Physicians' , Uterine Cervical Neoplasms , Humans , Female , Uterine Cervical Neoplasms/therapy , Uterine Cervical Neoplasms/pathology , France , Guideline Adherence/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Neoplasm Staging , Practice Guidelines as Topic , Positron Emission Tomography Computed Tomography , Oncologists , Radiation Oncologists , Patient Care Team , Surgeons , Surveys and Questionnaires
7.
J Surg Res ; 298: 137-148, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38603944

ABSTRACT

INTRODUCTION: Vascularized Composite Allografts (VCA) are usually performed in a full major histocompatibility complex mismatch setting, with a risk of acute rejection depending on factors such as the type of immunosuppression therapy and the quality of graft preservation. In this systematic review, we present the different immunosuppression protocols used in VCA and point out relationships between acute rejection rates and possible factors that might influence it. METHODS: This systematic review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. We systematically searched Medline (PubMed), Embase, and The Cochrane Library between November 2022 and February 2023, using following Mesh Terms: Transplant, Transplantation, Hand, Face, Uterus, Penis, Abdominal Wall, Larynx, and Composite Tissue Allografts. All VCA case reports and reviews describing multiple case reports were included. RESULTS: We discovered 211 VCA cases reported. The preferred treatment was a combination of antithymocyte globulins, mycophenolate mofetil (MMF), tacrolimus, and steroids; and a combination of MMF, tacrolimus, and steroids for induction and maintenance treatment, respectively. Burn patients showed a higher acute rejection rate (P = 0.073) and were administered higher MMF doses (P = 0.020). CONCLUSIONS: In contrast to previous statements, the field of VCA is not rapidly evolving, as it has encountered challenges in addressing immune-related concerns. This is highlighted by the absence of a standardized immunosuppression regimen. Consequently, more substantial data are required to draw more conclusive results regarding the immunogenicity of VCAs and the potential superiority of one immunosuppressive treatment over another. Future efforts should be made to report the VCA surgeries comprehensively, and muti-institutional long-term prospective follow-up studies should be performed to compare the number of acute rejections with influencing factors.


Subject(s)
Composite Tissue Allografts , Graft Rejection , Immunosuppressive Agents , Vascularized Composite Allotransplantation , Humans , Graft Rejection/immunology , Graft Rejection/prevention & control , Composite Tissue Allografts/immunology , Composite Tissue Allografts/transplantation , Immunosuppressive Agents/therapeutic use , Vascularized Composite Allotransplantation/adverse effects , Vascularized Composite Allotransplantation/methods , Immunosuppression Therapy/methods , Immunosuppression Therapy/adverse effects , Acute Disease
8.
J Gynecol Obstet Hum Reprod ; 53(7): 102778, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38570115

ABSTRACT

OBJECTIVES: To assess the benefit of surgical management of patients with endometriosis infiltrating pelvic nerves in terms of pain, analgesic consumption, and quality of life (QOL). METHODS: We conducted a retrospective cohort study In an Endometriosis referral center at a tertiary care university affiliated medical center. Patients diagnosed with endometriosis that underwent laparoscopic neurolysis for chronic pain were included. Patients rated their pain before and after surgery and differentiated between chronic pain and acute crises. Patients were requested to maintain a record of analgesic consumption and to evaluate their quality-of-life (QOL). RESULTS: Of the 21 patients in our study 15 (71.5 %) had obturator nerve involvement, 2 (9.5 %) had pudendal nerve involvement and 4 (19 %) had other pelvic nerve involvement. Median postoperative follow - up was of 8 months. All but 2 patients (9.6 %) had significant chronic pain improvement with a mean decrease of VAS of 3.05 (±2.5). Analgesic habits changed postoperatively with a significant decrease of 66 % of patients' daily consumption of any analgesics. Surgery improved QOL in 12 cases (57.1 %) and two patients (9.6 %) completely recovered with a high QOL. CONCLUSION: Neurolysis and excision of endometriosis of pelvic nerves could results in significant improvement of quality of life.

9.
Diagnostics (Basel) ; 14(7)2024 Mar 29.
Article in English | MEDLINE | ID: mdl-38611642

ABSTRACT

Pregnancy-related complications (PRC) impact maternal and fetal morbidity and mortality and place a huge burden on healthcare systems. Thus, effective diagnostic screening strategies are crucial. Currently, national and international guidelines define patients at low risk of PRC exclusively based on their history, thus excluding the possibility of identifying patients with de novo risk (patients without a history of disease), which represents most women. In this setting, previous studies have underlined the potential contribution of non-coding RNAs (ncRNAs) to detect patients at risk of PRC. However, placenta biopsies or cord blood samples are required, which are not simple procedures. Our review explores the potential of ncRNAs in biofluids (fluids that are excreted, secreted, or developed because of a physiological or pathological process) as biomarkers for identifying patients with low-risk pregnancies. Beyond the regulatory roles of ncRNAs in placental development and vascular remodeling, we investigated their specific expressions in biofluids to determine favorable pregnancy outcomes as well as the most frequent pathologies of pregnant women. We report distinct ncRNA panels associated with PRC based on omics technologies and subsequently define patients at low risk. We present a comprehensive analysis of ncRNA expression in biofluids, including those using next-generation sequencing, shedding light on their predictive value in clinical practice. In conclusion, this paper underscores the emerging significance of ncRNAs in biofluids as promising biomarkers for risk stratification in PRC. The investigation of ncRNA expression patterns and their potential clinical applications is of diagnostic, prognostic, and theragnostic value and paves the way for innovative approaches to improve prenatal care and maternal and fetal outcomes.

10.
J Robot Surg ; 18(1): 87, 2024 Feb 22.
Article in English | MEDLINE | ID: mdl-38386205

ABSTRACT

Surgery for deep endometriosis with colorectal involvement is an option after medical treatment failure. Over the past decade, robotic laparoscopy has emerged as an alternative to conventional laparoscopy. We aimed to evaluate surgical outcomes of robotic versus conventional laparoscopy for discoid excision and segmental resection. From 2019 to 2023, we conducted a retrospective cohort study of 152 consecutive patients with colorectal endometriosis who underwent robotic or conventional laparoscopy for discoid excision and colorectal resection. Ninety of the patients 152 underwent robotic surgery and 62 conventional laparoscopy. The mean total surgical room occupancy and operating times were longer in the robotic group: 270 ± 81 min vs 240 ± 79 min, p = 0.010, and 216 ± 78 min vs 190 ± 76, p = 0.027, respectively. The mean intraoperative blood loss, and the incidence of intra- and postoperative complications (according to Clavien-Dindo classification) were similar in the two groups. The mean hospital stay was greater after conventional laparoscopy (8 ± 5 vs 7 ± 4 days; p = 0.03), and the rate of persistent voiding dysfunction was higher in the conventional group (9/11, 25% vs 2/11, 5%; p = 0.01). A higher incidence of persistent voiding dysfunction was also observed after segmental resection by conventional laparoscopy (25% vs 4.8%, p = 0.01). Our results support the use of robotic surgery as an alternative to conventional laparoscopy for discoid excision and segmental resection for colorectal endometriosis.


Subject(s)
Colorectal Neoplasms , Endometriosis , Laparoscopy , Robotic Surgical Procedures , Female , Humans , Robotic Surgical Procedures/methods , Endometriosis/surgery , Retrospective Studies
11.
J Gynecol Obstet Hum Reprod ; 53(2): 102724, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38224817

ABSTRACT

OBJECTIVE: To analyze the literature and expose best evidence available regarding the benefit of pelvic examination for women with suspected endometriosis METHODS: the AGREE II and GRADE systems for grading scientific evidence. RESULTS: Endometriosis is characterized by the heterogeneity in its clinical presentation with many different symptoms reported by patients. In the literature, questioning for each symptom has a high sensitivity, reaching 76-98 %, but lacks specificity (20 - 58 %). The symptom-based approach is limited by its low specificity, the absence of external validation for most of the models developed and the inability to characterize the extent of the disease, which could have major implications in the decision - making process. The latest systematic review and meta-analysis included a total of 30 studies with 4,565 participants, compared the diagnostic performance of several modalities for endometriosis. Physical examination had a pooled sensitivity of 71 % and a specificity of 69 %, with an average diagnostic accuracy of 0.76. Overall, the value of pelvic examination is conferred by its high positive likehood ratio and specificity. Besides its diagnostic value, pelvic examination improves patients' management by allowing the identification of a possible myofascial syndrome as a differential diagnosis. It also increases the quality of the preoperative workup and influences the quality of surgical excision and decreases the time to diagnosis. CONCLUSION: Despite the lack of studies in the primary care context, pelvic examination (vaginal speculum and digital vaginal examination) increases the diagnostic value for suspected endometriosis in association with questioning for symptoms.


Subject(s)
Endometriosis , Gynecological Examination , Humans , Endometriosis/diagnosis , Endometriosis/complications , Female , Gynecological Examination/methods , Sensitivity and Specificity , Pelvic Pain/etiology , Pelvic Pain/diagnosis
12.
Eur J Obstet Gynecol Reprod Biol ; 294: 135-142, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38237312

ABSTRACT

OBJECTIVE: To assess the potential impact of the O-RADS MRI score on the decision-making process for the management of adnexal masses. METHODS: EURAD database (prospective, European observational, multicenter study) was queried to identify asymptomatic women without history of infertility included between March 1st and March 31st 2018, with available surgical pathology or clinical findings at 2-year clinical follow-up. Blinded to final diagnosis, we stratified patients into five categories according to the O-RADS MRI score (absent i.e. non adnexal, benign, probably benign, indeterminate, probably malignant). Prospective management was compared to theoretical management according to the score established as following: those with presumed benign masses (scored O-RADS MRI 2 or 3) (follow-up recommended) and those with presumed malignant masses (scored O-RADS MRI 4 or 5) (surgery recommended). RESULTS: The accuracy of the score for assessing the origin of the mass was of 97.2 % (564/580, CI95% 0.96-0.98) and was of 92.0 % (484/526) for categorizing lesions with a negative predictive value of 98.1 % (415/423, CI95% 0.96-0.99). Theoretical management using the score would have spared surgery in 229 patients (87.1 %, 229/263) with benign lesions and malignancy would have been missed in 6 borderline and 2 invasive cases. In patients with a presumed benign mass using O-RADS MRI score, recommending surgery for lesions >= 100 mm would miss only 4/77 (4.8 %) malignant adnexal tumors instead of 8 (50 % decrease). CONCLUSION: The use of O-RADS MRI scoring system could drastically reduce the number of asymptomatic patients undergoing avoidable surgery.


Subject(s)
Adnexal Diseases , Ovarian Neoplasms , Female , Humans , Adnexa Uteri/pathology , Adnexal Diseases/diagnostic imaging , Adnexal Diseases/surgery , Adnexal Diseases/pathology , Magnetic Resonance Imaging , Ovarian Neoplasms/diagnostic imaging , Ovarian Neoplasms/surgery , Predictive Value of Tests , Prospective Studies , Sensitivity and Specificity , Ultrasonography
13.
J Gynecol Obstet Hum Reprod ; 53(2): 102723, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38211693

ABSTRACT

OBJECTIVE: The objective of our study was to study the impact of discoid excision for deep endometriosis (DE) with colorectal involvement on fertility outcomes. METHODS: 49 patients with a desire for pregnancy treated with discoid excision for colorectal endometriosis in our endometriosis expert center between January 2015 and August 2020 were selected from our prospectively maintained database. Indications for surgery were either infertility and / or pelvic pain. Postoperative complications were graded according to the Clavien-Dindo classification. Fertility outcomes, both spontaneous and post-ART pregnancies, were analyzed. RESULTS: Among the 49 patients who underwent discoid excision exclusively (no other digestive resection) with a desire to conceive, 25 had a pregnancy after surgery and 24 did not. Double discoid excision was performed in 6.1 % of the cases (3/49). A colpectomy was performed in 12.2 % of the patients (6/49), and a protective stoma in 12.2 % (6/49). Fenestration of endometriomas was performed in 28.6 % of the patients (14/49), and parametrectomy in 40.8 % (20/49). The postoperative complication rate was 24.5 % (12/49) including 10.2 % (5/49) grade I, 12.2 % (6/49) grade II, and 2 % (1/49) grade III. Prior to surgery, 28 (57.1 %) patients had infertility including 13 (52 %) that successfully conceived following surgery and 15 (62.5 %) that remain infertile. Spontaneous pregnancy was achieved in 60 % (15/25) of infertile patients' prior surgery. The live-birth rate in patients conceiving spontaneously was 75 % (12/16). CONCLUSION: Our results support that discoid excision is safe and associated with good fertility outcomes. Whether first-line surgery using discoid excision is superior to first-line ART remains to be determined.


Subject(s)
Colorectal Neoplasms , Endometriosis , Infertility, Female , Rectal Diseases , Pregnancy , Female , Humans , Endometriosis/complications , Endometriosis/surgery , Rectal Diseases/surgery , Rectal Diseases/complications , Fertility , Infertility, Female/surgery , Infertility, Female/complications , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Colorectal Neoplasms/complications
14.
Insights Imaging ; 15(1): 29, 2024 Jan 30.
Article in English | MEDLINE | ID: mdl-38289563

ABSTRACT

Eighteen to 35% of adnexal masses remain non-classified following ultrasonography, leading to unnecessary surgeries and inappropriate management. This finding led to the conclusion that ultrasonography was insufficient to accurately assess adnexal masses and that a standardized MRI criteria could improve these patients' management. The aim of this work is to present the different steps from the identification of the clinical issue to the daily use of a score and its inclusion in the latest international guidelines. The different steps were the following: (1) preliminary work to formalize the issue, (2) physiopathological analysis and finding dynamic parameters relevant to increase MRI performances, (3) construction and internal validation of a score to predict the nature of the lesion, (4) external multicentric validation (the EURAD study) of the score named O-RADS MRI, and (5) communication and education work to spread its use and inclusion in guidelines. Future steps will include studies at patients' levels and a cost-efficiency analysis. Critical relevance statement We present translating radiological research into a clinical application based on a step-by-step structured and systematic approach methodology to validate MR imaging for the characterization of adnexal mass with the ultimate step of incorporation in the latest worldwide guidelines of the O-RADS MRI reporting system that allows to distinguish benign from malignant ovarian masses with a sensitivity and specificity higher than 90%. Key points • The initial diagnostic test accuracy studies show the limitation of a preoperative assessment of adnexal masses using solely ultrasonography.• The technical developments (DCE/DWI) were investigated with the value of dynamic MRI to accurately predict the nature of benign or malignant lesions to improve management.• The first developing score named ADNEX MR Score was constructed using multiple easily assessed criteria on MRI to classify indeterminate adnexal lesions following ultrasonography.• The multicentric adnexal study externally validated the score creating the O-RADS MR score and leading to its inclusion for daily use in international guidelines.

15.
NEJM Evid ; 2(7): EVIDoa2200282, 2023 Jul.
Article in English | MEDLINE | ID: mdl-38320163

ABSTRACT

BACKGROUND: The discovery of a saliva-based micro­ribonucleic acid (miRNA) signature for endometriosis in 2022 opened up new perspectives for early and noninvasive diagnosis of the disease. The 109-miRNA saliva signature is the product of miRNA biomarkers and artificial intelligence (AI) modeling. We designed a multicenter study to provide external validation of its diagnostic accuracy. We present here an interim analysis. METHODS: The first 200 patients included in the multicenter prospective ENDOmiRNA Saliva Test study (NCT05244668) were included for interim analysis. The study population comprised women from 18 to 43 years of age with a formal diagnosis of endometriosis or with suspected endometriosis. Epidemiologic, clinical, and saliva sequencing data were collected between November 2021 and March 2022. Genomewide miRNA expression profiling by small RNA sequencing using next-generation sequencing (NGS) was performed, and a random forest algorithm was used to assess the diagnostic accuracy. RESULTS: In this interim analysis of the external validation cohort, with a population prevalence of 79.5%, the 109-miRNA saliva diagnostic signature for endometriosis had a sensitivity of 96.2% (95% confidence interval [CI], 93.7 to 97.3%), specificity of 95.1% (95% CI, 85.2 to 99.1%), positive predictive value of 95.1% (95% CI, 85.2 to 99.1%), negative predictive value of 86.7% (95% CI, 77.6 to 90.3%), positive likelihood ratio of 19.7 (95% CI, 6.3 to 108.8), negative likelihood ratio of 0.04 (95% CI, 0.03 to 0.07), and area under the receiver operating characteristic curve of 0.96 (95% CI, 0.92 to 0.98). CONCLUSIONS: The use of NGS and AI in the sequencing and analysis of miRNA provided a saliva-based miRNA signature for endometriosis. Our interim analysis of a prospective multicenter external validation study provides support for its ongoing investigation as a diagnostic tool. (Funded by Ziwig and the Conseil Régional d'Ile de France [Grant EX024087]; ClinicalTrials.gov number, NCT05244668.)


Subject(s)
Endometriosis , MicroRNAs , Female , Humans , MicroRNAs/genetics , Endometriosis/diagnosis , Prospective Studies , Reproducibility of Results , Biomarkers, Tumor/genetics
SELECTION OF CITATIONS
SEARCH DETAIL