UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060521 |
|---|---|
| Receipt number | R000068955 |
| Scientific Title | Clinical Performance Evaluation of a Novel Multigene Panel Test |
| Date of disclosure of the study information | 2026/01/30 |
| Last modified on | 2026/01/30 14:43:29 |
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Basic information
Public title
Clinical Performance Study of a Novel Multigene Panel Test(BRANCH Ancillary Study 01)
Acronym
BRANCH Ancillary Study 01
Scientific Title
Clinical Performance Evaluation of a Novel Multigene Panel Test
Scientific Title:Acronym
BRANCH Ancillary Study 01
Region
| Japan |
Condition
Condition
Breast cancer, pancreatic cancer, prostate cancer, ovarian cancer, other gynecologic cancers, retroperitoneal or peritoneal tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Breast surgery |
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
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
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
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
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
121
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kuwata |
Organization
National Cancer Center Hospital East
Division name
Department of Genetic Medicine and Service
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
tkuwata@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kuwata |
Organization
National Cancer Center Hospital East
Division name
Department of Genetic Medicine and Service
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
Homepage URL
tkuwata@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Falco Biosystems Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Falco Biosystems Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立がん研究センター東病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is conducted as an ancillary study to the observational BRANCH study.
Residual blood specimens and existing clinical information collected in the BRANCH study will be secondarily used.
No additional sample collection or clinical intervention will be performed.
The 32-gene multigene panel test (32MGP) is conducted for research purposes only, and test results will not be returned to participants.
Management information
Registered date
| 2026 | Year | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068955
