Clinical Performance Study of a Novel Multigene Panel Test(BRANCH Ancillary Study 01)

Clinical Performance Evaluation of a Novel Multigene Panel Test - BRANCH Ancillary Study 01

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060521

Enrollment

121

Registered

2026-01-30

Start date

2026-01-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, pancreatic cancer, prostate cancer, ovarian cancer, other gynecologic cancers, retroperitoneal or peritoneal tumors

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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 The patient provided consent for secondary use of specimens at the time of BRANCH study enrollment and has not withdrawn consent. 2.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.

Exclusion criteria

Exclusion criteria: Patients deemed inappropriate for enrollment in this ancillary study by the attending physician.

Design outcomes

Primary

Measure	Time frame
The Statistical Analysis Department will link the study registration number with the double-coded identification number using a correspondence table. Using the BRCA1 and BRCA2 results obtained by the 32MGP as the index test and the BRACAnalysis results as the reference standard, the following performance metrics will be calculated: positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement. PPA = (Number of specimens with concordant positive results between 32MGP and BRACAnalysis / Number of specimens positive by BRACAnalysis) x 100 NPA = (Number of specimens with concordant negative results between 32MGP and BRACAnalysis / Number of specimens negative by BRACAnalysis) x 100 Overall percent agreement = (Number of specimens with concordant results / Total number of specimens tested by BRACAnalysis) x 100	—

Measure

Time frame

The Statistical Analysis Department will link the study registration number with the double-coded identification number using a correspondence table. Using the BRCA1 and BRCA2 results obtained by the 32MGP as the index test and the BRACAnalysis results as the reference standard, the following performance metrics will be calculated: positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement. PPA = (Number of specimens with concordant positive results between 32MGP and BRACAnalysis / Number of specimens positive by BRACAnalysis) x 100 NPA = (Number of specimens with concordant negative results between 32MGP and BRACAnalysis / Number of specimens negative by BRACAnalysis) x 100 Overall percent agreement = (Number of specimens with concordant results / Total number of specimens tested by BRACAnalysis) x 100

—

Countries

Japan

Contacts

Public ContactTakeshi Kuwata

National Cancer Center Hospital East Department of Genetic Medicine and Service

tkuwata@east.ncc.go.jp04-7133-1111

Outcome results