Evaluation of clinical effects of a multidisciplinary-collaborated cancer support team for gastrointestinal cancer chemotherapy: prospective observational study protocol of M-CAST study.

BACKGROUND: Although the multidisciplinary-collaborated team approach in cancer treatment has recently become popular, prospectively evaluated evidence is limited. We started a multidisciplinary-collaborated cancer support team (MCST) to facilitate cooperation across multidisciplinary medical staff in our hospital and established clinical evidence of supportive care. This study aimed to prospectively evaluate the clinical activity and effect of MCST in patients with gastrointestinal cancer receiving chemotherapy. METHODS: This is a single-center, single-arm, observational study. Patients with gastrointestinal cancer scheduled to receive chemotherapy are enrolled and supported by the MCST. The primary endpoints are the number of interventions by medical staff and the number of patients who showed improvement in side effects. The secondary endpoints are the severity of side effects, medical expenses, number of consultations, the acceptance rate of prescription recommendations, adjuvant chemotherapy completion rates, dose intensity, and time required for co-medical intervention. In addition, medical staff and attending physicians evaluate all adverse events. DISCUSSION: This study is expected to contribute to establishing new cancer-supportive care teams for patients with gastrointestinal cancer receiving chemotherapy and those with cancer receiving chemotherapy. TRIAL REGISTRATION: This trial was registered in the Japan Registry of Clinical Trials (jRCT) as jRCT1030220495. The date of first registration, 29/11/2022, https://jrct.niph.go.jp/search.

Evaluation of human immunodeficiency virus-1/2 antigen/antibody immunochromatographic assay.

BACKGROUND: In Japan, an immunochromatographic HIV-1/2 assay has been used for local Health Care Centers to prevent HIV spread in early stages and for hospitals at night or on holidays, where automated instruments are not available. In 2009, a new immunochromatographic HIV-1/2 assay became available which detects both antigen (Ag) and antibody (Ab) simultaneously and on separate bars. This study was conducted to evaluate the clinical performance of this new assay against three HIV-1/2 assays. METHODS: One immunochromatographic assay (ICA) for HIV Ab detection, one chemiluminescent enzyme immunoassay (CLEIA) for Ab detection and one ELISA for Ag/Ab combination assay were evaluated with the ICA for Ag/Ab detection. Serum samples from 955 patients were used at Osaka University Hospital, who had been tested initially for HIV infection status. The 900 were negative and 55 were positive. In addition, the samples in 10 commercially available panels [2 containing relatively rare HIV subtypes/genotypes and 8 containing seroconversion samples] were tested using all HIV assays. RESULTS: The HIV Ag/Ab ICA showed 100% (900/900, 95% confidence interval (95 CI) 99.59 - 100%) clinical specificity and was better than 99.8% (898/900, 95 CI 99.20 - 99.97%) of the existing ICA. The CLEIA and ELISA showed 100% (600/600, 95 CI 99.39 - 100%) and 99.8% (598/600, 95 CI 98.80 - 99.96%) specificity, respectively. The HIV Ag/Ab ICA showed 100% (55/55, 95 CI 93.51 - 100%) clinical sensitivity and detected all the relatively rare HIV subtypes/genotype panels; these results were the same as the other three assays. The HIV Ag/Ab ICA detected 5 seroconversion panels earlier than antibody-only-detection assays but detected later with 2 panels than ELISA for Ag/Ab combination assay. CONCLUSIONS: The HIV Ag/Ab ICA demonstrated good performances in clinical specificity and sensitivity as a rapid assay and is a suitable assay for qualitative judgement of HIV Ag and Ab simultaneously in human serum and plasma.