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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046085
Receipt No. R000052607
Scientific Title Observational study to evaluate the utility of confirmation of germline mutations in patients with solid tumors and relatives
Date of disclosure of the study information 2021/11/16
Last modified on 2021/11/16

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Basic information
Public title Observational study to evaluate the utility of confirmation of germline mutations in patients with solid tumors and relatives
Acronym BRANCH study
Scientific Title Observational study to evaluate the utility of confirmation of germline mutations in patients with solid tumors and relatives
Scientific Title:Acronym BRANCH study
Region
Japan

Condition
Condition Hereditary cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Cardiology
Pneumology Endocrinology and Metabolism Hematology and clinical oncology
Nephrology Neurology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Chest surgery Breast surgery
Obsterics and gynecology Ophthalmology Dermatology
Oto-rhino-laryngology Urology Neurosurgery
Adult
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Patients with solid tumors in which presumed germline pathogenic variants are identified by circulating tumor DNA (ctDNA) or cancer genome profiling (CGP) of tumor tissues will be tested for confirmed pathogenic germline variants (PGVs). We will compare the utility of liquid biopsy and tumor tissue CGP in identifying PGVs, and evaluate the utility of multi-gene panel (MGP) analysis in identifying hereditary cancer (cohort A/B). In addition, we will evaluate the feasibility of PGV carrier diagnosis for relatives of patients with confirmed PGV (Cohort C).
Basic objectives2 Others
Basic objectives -Others This study is an observational study to: 1) perform a PGPV confirmation test for PGPV detected by liquid biopsy or tumor tissue CGP, and compare the appropriate VAF cutoff for PGV estimation between tumor tissue CGP and liquid biopsy, and 2) clarify the feasibility of diagnosing PGV carriers in relatives of patients with confirmed PGV.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PGV identification rate based on PGPV in liquid biopsy and
sensitivity and specificity for confirmation of PGV at different VAF cutoffs.
Key secondary outcomes 1. PGV identification rate based on PGPV in tumor tissue CGP and
sensitivity and specificity for confirmation of PGV at different VAF cutoffs.
2. characteristics of the background of patients with confirmed PGPV in liquid biopsy
3. newly detected/confirmed PGV by MGP
4. usefulness of diagnosis for carriers in first-degree relatives of confirmed PGV patients

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Cohort A: Diagnosed with solid tumors and meet the following (1), (2), or (3).
(1) PGPV with a VAF of 10% or higher has been identified in the GOZILA study, MONSTAR-SCREEN, or liquid biopsy or tumor tissue CGP in clinical practice.
(2) PGPVs presumed to be PGVs have been identified in the GOZILA study or MONSTAR-SCREEN.
(3) PGPV with a VAF of 10% or higher has been identified by liquid biopsy in clinical practice.
2) Cohort B: Patients diagnosed with solid tumors, and without consent for this study due to the patient's passing or other reasons, but meet the following (1)-(2).
(1) PGPV has been identified by GOZILA study, MONSTAR-SCREEN, liquid biopsy or tumor tissue CGP in clinical practice(1) or (2) applies regardless of whether the patient has a solid cancer diagnosis.
(1) First-degree relatives of patients with confirmed PGV in Cohort A or MONSTAR-SCREEN-2.
(2) Relatives of a patient with confirmed PGV who does not meet (1) but has been confirmed eligible by the study office.
Key exclusion criteria 1.The physician in charge determines that the research subject is unsuitable for enrollment in this study in light of the subject's physical or mental condition.
2. Patients has a history of bone marrow transplantation.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Yoshiaki
Middle name
Last name Nakamura
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and GI Oncology / Translational Research Support Section
Zip code 277-8577
Address 6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL 04-7133-1111
Email yoshinak@east.ncc.go.jp

Public contact
Name of contact person
1st name Yumie
Middle name
Last name Hiraoka
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
Email yhiraoka@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (KAKENHI)
FALCO biosystems Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
Email NCC_IRBoffice@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

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 16 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 Preinitiation
Date of protocol fixation
2021 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2022 Year 02 Month 14 Day
Last follow-up date
2031 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 an observational study to: 1) perform a PGPV confirmation test for PGPV detected by liquid biopsy or tumor tissue CGP, and compare the appropriate VAF cutoff for PGV estimation between tumor tissue CGP and liquid biopsy, and 2) clarify the feasibility of diagnosing PGV carriers in relatives of patients with confirmed PGV.

Management information
Registered date
2021 Year 11 Month 16 Day
Last modified on
2021 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052607

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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