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Prospective Cohort Study of Variant Carriers With BRCA1 or BRCA2

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ClinicalTrials.gov Identifier: NCT03296826
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborators:
Keio University
Japanese Gynecologic Oncology Group (JGOG)
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Brief 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.

Condition or disease
BRCA1 and/or BRCA2 Variant Carriers Ovarian Carcinoma Fallopian Tube Carcinoma Peritoneal Carcinoma

Detailed Description:
  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.

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prospective Cohort Study of Variant Carriers With BRCA1 and BRCA2
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : March 31, 2032
Estimated Study Completion Date : March 31, 2032


Group/Cohort
BRCA1/2 variant carriers
Japanese women who carry BRCA 1/2 variants.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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. [ Time Frame: up to 15 years ]
    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.

  2. Death from any cause [ Time Frame: up to 15 years ]
    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.

  3. Deaths from ovarian, fallopian tube, and peritoneal cancers. [ Time Frame: up to 15 years ]
    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.

  4. Establishing the detection rate of occult cancer based on histopathological evaluations of samples from RRSO. [ Time Frame: up to 15 years ]
    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.

  5. Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period. [ Time Frame: up to 15 years ]
    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.

  6. Death from any cause, including post-RRSO period. [ Time Frame: up to 15 years ]
    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.


Biospecimen Retention:   Samples With DNA
Blood samples (all subjects) for Germ-line DNA sequencing, Biospy samples(when subjects have RRSO within follow-up duration)


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
BRCA1 and/or BRCA2 variant carriers
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296826


Contacts
Contact: Akira Hirasawa, MD, Ph.D +81-3-3353-1211 hir-aki45@umin.org

Locations
Japan
Keio University Recruiting
Tokyo, Japan
Contact: Akira Hirasawa, MD         
Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Keio University
Japanese Gynecologic Oncology Group (JGOG)
Investigators
Study Chair: Akira Hirasawa, MD, Ph.D Keio University

Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT03296826     History of Changes
Other Study ID Numbers: JGOG3024
UMIN000028740 ( Registry Identifier: UMIN-CTR )
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases