ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme®.

BACKGROUND: Colorectal cancer is a major public concern, being the second deadliest cancer in the world. Whereas survival is high for localized forms, metastatic colorectal cancer has showed poor prognosis, with a 5-year survival barely surpassing 11%. Conventional chemotherapies against this disease proved their efficiency and remain essential in first-line treatment. However, the large number of authorized protocols complexifies treatment decision. In common practice, such decision is made on an empirical basis, by assessing benefits and risks for the patient. In other words, there is currently no efficient means of predicting the efficacy of any chemotherapy protocol for metastatic colorectal cancer. METHODS/DESIGN: The use of a chemosensitivity assay, the Oncogramme®, should help clinicians administer the best chemotherapy regimen to their patients. We hypothesize it would ultimately improve their survival. In this multicentred, prospective trial (ONCOGRAM), eligible patients with metastatic colorectal cancer are randomized to determine whether they will receive an Oncogramme®. For clinicians whose patients benefited from the assay (arm A), results are used as a decision support tool. Patients not undergoing the Oncogramme® procedure are treated according to current practice, without the assistance of the assay (arm B). Primary outcome is 1-year progression-free survival. Secondary outcomes include response rates, as well as 6-month and 1-year survival rates. DISCUSSION: This study aims at investigating the clinical utility of the Oncogramme® as a decision support tool for the treatment of patients with metastatic colorectal cancer. If the Oncogramme® positively influenced patient overall survival and/or progression-free survival, it would be of great value for clinicians to implement this assay within the current landscape of personalized medicine tools, which include genomics and biomarker assays. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03133273 . Registered on April 28, 2017.

Accuracy of Teledentistry for Diagnosing Dental Pathology Using Direct Examination as a Gold Standard: Results of the Tel-e-dent Study of Older Adults Living in Nursing Homes.

IMPORTANCE: Dental neglect and high levels of unmet dental needs are becoming increasingly prevalent among elderly residents of long-term care facilities, although frail, elderly, and dependent populations are the most in need of professional dental care. Little is known about the validity of teledentistry for diagnosing dental pathology in nursing home residents. OBJECTIVES: To evaluate the accuracy of teledentistry for diagnosing dental pathology, assessing the rehabilitation status of dental prostheses, and evaluating the chewing ability of older adults living in nursing homes (using direct examination as a gold standard). DESIGN: Multicenter diagnostic accuracy study performed in France and Germany. SETTING: Eight nursing homes in France and Germany. PARTICIPANTS: Nursing home residents with oral or dental complaints, self-reported or reported by caregivers, willing to receive oral or dental preventive care. In total, 235 patients were examined. The mean age was 84.4 ± 8.3 years, and 59.1% of the subjects were female. INTERVENTION: The patients were examined twice. Each patient was his or her own control. First, the dental surgeon established a diagnosis by reviewing a video recorded in the nursing home and accessed remotely. Second, within a maximum of 7 days, patients were examined conventionally (face-to-face) by the same surgeon who established the initial diagnosis. MEASUREMENTS: All residents received a comprehensive clinical examination in their home by a trained geriatrician and underwent a dental hygiene evaluation that used the Silness-Loe and Greene-Vermillion dental hygiene assessment indices. The diagnoses established via the video recording and in the face-to-face setting were compared. The main outcome measure was number of dental pathologies. RESULTS: In total, 128 (55.4%) patients had a dental pathology. The sensitivity of teledentistry for diagnosing dental pathology was 93.8% (95% confidence interval [CI] 90.7-96.9), and the specificity was 94.2% (95% CI 91.2-97.2). Among the 128 cases of dental pathology identified by teledentistry, 6 (4.8%) were false positives. The teledentistry assessments were quicker than the face-to-to-face examinations (12 and 20 minutes, respectively). CONCLUSIONS: Teledentistry showed excellent accuracy for diagnosing dental pathology in older adults living in nursing homes; its use may allow more regular checkups to be carried out by dental professionals.