UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028740 |
|---|---|
| Receipt number | R000032891 |
| Scientific Title | Prospective cohort study of germline variant carriers with BRCA1 and BRCA2 (JGOG3024/KGOG3055) |
| Date of disclosure of the study information | 2017/08/19 |
| Last modified on | 2022/02/24 18:38:12 |
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Basic information
Public title
Prospective cohort study of germline variant carriers with BRCA1 and BRCA2 (JGOG3024/KGOG3055)
Acronym
Prospective cohort study of germline variant carriers with BRCA1 and BRCA2 (JGOG3024/KGOG3055)
Scientific Title
Prospective cohort study of germline variant carriers with BRCA1 and BRCA2 (JGOG3024/KGOG3055)
Scientific Title:Acronym
Prospective cohort study of germline variant carriers with BRCA1 and BRCA2 (JGOG3024/KGOG3055)
Region
| Japan | Asia(except Japan) |
Condition
Condition
Hereditary breast and ovarian cancer
BRCA1 and/or BRCA2 variant carriers
ovarian, fallopian tube, and peritoneal carcinoma
Classification by specialty
| Obstetrics and Gynecology | Adult |
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
1600
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Hirasawa |
Organization
Okayama University
Division name
Department of Clinical Genomic Medicine, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL
086-223-7151
hir-aki45@umin.org
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Sano |
Organization
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
Division name
Devision of project management
Zip code
650-0047
Address
1-5-4 Minatojima-minamimachi, chuo-ku Kobe, 650-0047 Japan
TEL
078-303-9108
Homepage URL
y-sano@tri-kobe.org
Sponsor or person
Institute
Japanese Gynecologic Oncology Group(JGOG)
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Korean Gynecologic Oncology Group
Name of secondary funder(s)
NRF(National Research Foundation of Korea)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.ac.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
JGOG/KGOG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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2032 | Year | 02 | Month | 27 | Day |
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.
International collaboration study with the Korean Gynecologic Oncology Group (KGOG).
Management information
Registered date
| 2017 | Year | 08 | Month | 19 | Day |
Last modified on
| 2022 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032891
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