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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028740
Receipt No. R000032891
Scientific Title Prospective cohort study of variant carriers with BRCA1 and BRCA2.
Date of disclosure of the study information 2017/08/19
Last modified on 2017/11/25

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Basic information
Public title Prospective cohort study of variant carriers with BRCA1 and BRCA2.
Acronym Prospective cohort study of variant carriers with BRCA1 or BRCA2 (JGOG3024)
Scientific Title Prospective cohort study of variant carriers with BRCA1 and BRCA2.
Scientific Title:Acronym Prospective cohort study of variant carriers with BRCA1 or BRCA2 (JGOG3024)
Region
Japan

Condition
Condition BRCA1 and/or BRCA2 variant carriers
ovarian, fallopian tube, and peritoneal carcinoma
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To determine the incidence and risk factors in the development of ovarian, fallopian tube, and peritoneal cancers in Japanese women carrying BRCA1/2 variants.
Basic objectives2 Others
Basic objectives -Others 1. To estimate the incidence of ovarian, fallopian tube and peritoneal cancers in women carrying BRCA1/2 variants.
2. To investigate risk factors concerning the development of ovarian, fallopian tube, and peritoneal cancers (loci of BRCA1/2 genetic variants, modifier genes, genetic polymorphism, hormones, and lifestyle habits.) in women carrying BRCA1/2 variants.
3. To estimate the detection rates of occult cancer based on histopathological evaluations, using risk-reducing salpingo-oophorectomy (RRSO).
4. To examine the risk-reducing effect of RRSO on the development of ovarian, fallopian tube, and peritoneal cancers in women carrying BRCA1/2 variants, and compare with those not undergoing RRSO.
5. To identify clinicopathological features in women carrying BRCA1/2 variants who had undergone RRSO.
6. To identify the appropriate interval or degree of surveillance.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Occurrence of ovarian, fallopian tube, and peritoneal carcinoma
Key secondary outcomes (1)Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer, based on evaluations of histopathological samples taken post-RSSO.
(2) Death from any cause
(3) Deaths from ovarian, fallopian tube, and peritoneal cancers.
(4) Establishing the detection rate of occult cancer based on histopathological evaluations of samples from RRSO.
(5) Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period.
(6)Death from any cause, including post-RRSO period.

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 Female
Key inclusion criteria (1) Women carrying BRCA1/2 variants (those with either BRCA1 or BRCA2 variants, or those carrying both variants) and women carrying a variant of uncertain significance (VUS).
(2) Women who have received sufficient genetic counseling at any medical institution, prior to enrollment to the study.
(3) Women who provide consent should be 20 years of age or older.
(4) Women who provide written consent.
Key exclusion criteria (1) Women without ovarian or fallopian tube cancer at the time of informed consent.
(2) Women previously diagnosed with ovarian, fallopian tube, or peritoneal cancer, and not excluding those with a personal history of breast cancer development.
(3)Other individuals considered inappropriate for involvement in this study by the investigator.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Hirasawa
Organization Keio University School of Medicine
Division name Department of Obstetrics & Gynecology
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, 160-8582, Japan
TEL 03-3353-1211(62386)
Email hir-aki45@umin.org

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Nakagawa
Organization Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Division name Devision of project management
Zip code
Address 1-5-4 Minatojima-minamimachi, chuo-ku Kobe, 650-0047 Japan
TEL 078-303-9108
Homepage URL
Email s-nakagawa@tri-kobe.org

Sponsor
Institute Japanese Gynecologic Oncology Group(JGOG)
Institute
Department

Funding Source
Organization Self funding among JGOG
(Applying public funding)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 JGOG参加施設

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 19 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
2017 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The Japanese Gynecologic Oncology Group (JGOG) and
Tohoku Medical Megabank Organization (ToMMo) constructed a joint biobank (JGOG/ToMMo biobank). Germline DNAs from this study are collected and stored to the JGOG/ToMMo biobank.

Management information
Registered date
2017 Year 08 Month 19 Day
Last modified on
2017 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032891

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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