Tokyo, Jan. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060521) titled 'Clinical Performance Study of a Novel Multigene Panel Test(BRANCH Ancillary Study 01)' on Jan. 30.

Study Type: Observational

Primary Sponsor: Institute - National Cancer Center Hospital East

Condition: Condition - Breast cancer, pancreatic cancer, prostate cancer, ovarian cancer, other gynecologic cancers, retroperitoneal or peritoneal tumors Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - As an ancillary study of the BRANCH study, this clinical performance study will be conducted using residual specimens from patients with solid tumors enrolled in Cohort D, who underwent BRCA1 and BRCA2 genetic testing (hereinafter referred to as BRACAnalysis) under insurance-covered medical care. A novel 32-gene multigene panel test (hereinafter referred to as 32MGP) will be performed using these residual specimens, and the results will be compared with the BRACAnalysis results previously obtained in the BRANCH study to evaluate clinical performance. Basic objectives2 - Bio-equivalence

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients enrolled in the BRANCH study who meet all of the following criteria: 1. The patient provided consent for secondary use of specimens at the time of BRANCH study enrollment and has not withdrawn consent. 2. The patient is registered in the insurance-covered BRACAnalysis cohort (Cohort D). 3. Sufficient residual blood specimens are available to perform the 32MGP.

Rationale: All patients registered in the BRANCH study based on BRACAnalysis results for whom the BRACAnalysis report status can be confirmed will be included. Key exclusion criteria - Patients deemed inappropriate for enrollment in this ancillary study by the attending physician. Target Size - 121

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 01 Month 23 Day Date of IRB - 2026 Year 01 Month 23 Day Anticipated trial start date - 2026 Year 01 Month 30 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068955

Disclaimer: Curated by HT Syndication.