BRCA1 and/or BRCA2 Variant CarriersNCT03296826
Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2
An observational study of BRCA1 and/or BRCA2 Variant Carriers and Ovarian Carcinoma, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
To determine the incidence and risk factors in the development of ovarian, fallopian tube, and peritoneal cancers in Japanese women carrying Breast Cancer Susceptibility Gene (BRCA)1/2 variants. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- BRCA1 and/or BRCA2 Variant Carriers, Ovarian Carcinoma, Fallopian Tube Carcinoma
- How many people
- 600 participants
- Where
- 1 siteJapan
- Study dates
- 8 Nov 2017to 31 Mar 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: BRCA1 and/or BRCA2 variant carriers
Who may be able to join
- 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).
- Women who have received sufficient genetic counseling at any medical institution, prior to enrollment to the study.
- Women who provide consent should be 20 years of age or older.
- Women who provide written consent.
Who cannot join
- Women without ovarian or fallopian tube cancer at the time of informed consent.
- Women previously diagnosed with ovarian, fallopian tube, or peritoneal cancer, and not excluding those with a personal history of breast cancer development.
- Other individuals considered inappropriate for involvement in this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Okayama University
Okayama
Akira Hirasawa, M.D., Ph.D.
About this study
To determine the incidence and risk factors in the development of ovarian, fallopian tube, and peritoneal cancers in Japanese women carrying Breast Cancer Susceptibility Gene (BRCA)1/2 variants.
Read the detailed description
- To estimate the incidence of ovarian, fallopian tube and peritoneal cancers in women carrying BRCA1/2 variants.
- 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.
- To estimate the detection rates of occult cancer based on histopathological evaluations, using risk-reducing salpingo-oophorectomy (RRSO).
- 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.
- To identify clinicopathological features in women carrying BRCA1/2 variants who had undergone RRSO.
- To identify the appropriate interval or degree of surveillance.
- Conditions
- BRCA1 and/or BRCA2 Variant Carriers, Ovarian Carcinoma, Fallopian Tube Carcinoma, Peritoneal Carcinoma
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BRCA1/2 variant carriers | Japanese women who carry BRCA 1/2 variants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of ovarian, fallopian tube, and peritoneal carcinoma
Occurrence of ovarian, fallopian tube, and peritoneal carcinoma is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct
Measured: up to 15 years
Secondary outcomes (6)
Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer, based on evaluations of histopathological samples taken post-RSSO.
Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct. The occult cancer is defined as ovarian, fallopian tube, peritoneal, and uterine carcinomas (including serious tubal intraepithelial carcinoma, STIC), which is based on evaluations of histopathological samples taken post-RSSO.
Measured: up to 15 years
Death from any cause
Death from any cause is a duration from the date of enrollment to the date of death from any cause. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct.
Measured: up to 15 years
Deaths from ovarian, fallopian tube, and peritoneal cancers.
Deaths from ovarian, fallopian tube, and peritoneal cancers is a duration from the date of enrollment to the date of death from these cancers. If the subjects have undergone RRSO, the term is defined from the date of enrollment to the date of RRSO undergone.
Measured: up to 15 years
Establishing the detection rate of occult cancer based on histopathological evaluations of samples from RRSO.
The occult cancer is defined as ovarian, fallopian tube, peritoneal, and uterine carcinomas (including serious tubal intraepithelial carcinoma, STIC), which is based on evaluations of histopathological samples taken post-RSSO.
Measured: up to 15 years
Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period.
Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal cancer, including in the post-RRSO period.
Measured: up to 15 years
Death from any cause, including post-RRSO period.
Death from any cause, including post-RRSO period is a duration from the date of enrollment to the date of death from any cause, including in the post-RRSO period.
Measured: up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start8 Nov 2017
- Primary completion31 Mar 2032 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA1 and/or BRCA2 Variant CarriersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Okayama University, Japanese Gynecologic Oncology Group
- Responsible party
- Sponsor
- Investigators
- Akira Hirasawa, M.D., Ph.D., Study chair, Okayama University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296826
- Sponsor's protocol ID
- JGOG3024
- Other IDs
- UMIN000028740
- Status last verified
- Jan 2026
- First submitted
- 25 Sep 2017
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2
- ClinicalTrials.gov ID
- NCT03296826
- Acronym / sponsor ID
- JGOG3024
- Conditions
- BRCA1 and/or BRCA2 Variant Carriers, Ovarian Carcinoma, Fallopian Tube Carcinoma, Peritoneal Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Okayama University, Japanese Gynecologic Oncology Group
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 31 Mar 2032 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the incidence and risk factors in the development of ovarian, fallopian tube, and peritoneal cancers in Japanese women carrying Breast Cancer Susceptibility Gene (BRCA)1/2 variants.
Detailed description
- To estimate the incidence of ovarian, fallopian tube and peritoneal cancers in women carrying BRCA1/2 variants.
- 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.
- To estimate the detection rates of occult cancer based on histopathological evaluations, using risk-reducing salpingo-oophorectomy (RRSO).
- 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.
- To identify clinicopathological features in women carrying BRCA1/2 variants who had undergone RRSO.
- To identify the appropriate interval or degree of surveillance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRCA1/2 variant carriers | – | –Japanese women who carry BRCA 1/2 variants. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- BRCA1 and/or BRCA2 variant carriers
Key inclusion criteria (4 listed)
- 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).
- Women who have received sufficient genetic counseling at any medical institution, prior to enrollment to the study.
- Women who provide consent should be 20 years of age or older.
- Women who provide written consent.
Key exclusion criteria (3 listed)
- Women without ovarian or fallopian tube cancer at the time of informed consent.
- Women previously diagnosed with ovarian, fallopian tube, or peritoneal cancer, and not excluding those with a personal history of breast cancer development.
- Other individuals considered inappropriate for involvement in this study by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of ovarian, fallopian tube, and peritoneal carcinoma
Time frame: up to 15 years
Occurrence of ovarian, fallopian tube, and peritoneal carcinoma is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct
6 secondary outcomes
Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer, based on evaluations of histopathological samples taken post-RSSO.
Time frame: up to 15 years
Death from any cause
Time frame: up to 15 years
Deaths from ovarian, fallopian tube, and peritoneal cancers.
Time frame: up to 15 years
Establishing the detection rate of occult cancer based on histopathological evaluations of samples from RRSO.
Time frame: up to 15 years
Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period.
Time frame: up to 15 years
Death from any cause, including post-RRSO period.
Time frame: up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
Related trials for BRCA1 and/or BRCA2 Variant Carriers
Not yet recruitingObservational study
Study on Fertility Parameters in Women With Germline Variants in BRCA1 and BRCA2
BRCA1 and/or BRCA2 Variant Carriers, Fertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akira Hirasawa, M.D., Ph.D. study chair
Okayama University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BRCA1 and/or BRCA2 Variant Carriers and Ovarian Carcinoma, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akira Hirasawa, M.D., Ph.D. (+81-86-235-7436, hir-aki45@umin.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of ovarian, fallopian tube, and peritoneal carcinoma (time frame: up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.