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Trial record 2 of 200 for:    brca | Recruiting, Not yet recruiting, Available Studies

Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome.

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ClinicalTrials.gov Identifier: NCT02341118
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

BRCA1 or BRCA2 genes, are implicated in 10-15% of ovarian cancer cases, increased to 22% germline BRCA1/2 mutation frequency in patients with high grade serous histology subtype, including those women who have no family history of breast or ovarian cancer. With the rapid advancement of therapeutics targeted this population, this protocol seeks to provide genetic BRCA1/2 screening to all patients with high grade serous ovarian cancer. This information may help in selection of future treatment options and genetic testing for BRCA1/2 may be used to potentially prevent a proportion of cancer for the family members.

This study will be an opportunity for patient to improve access at genetic and molecular testing for BRCA1/2 mutation which could impact her future treatment option. Moreover, this study will allow to prospectively assess the proportion of patients with BRCA mutation in ovarian cancer and describe the type of mutations identified in a large population.


Condition or disease Intervention/treatment
Ovarian Cancer Genetic: BRCA genetic data

Detailed Description:

Primary Objectives

· To provide genomic profiling for BRCA1 and BRCA2 mutational status in patients' with high grade serous ovarian cancer.

Secondary Objectives

  • To track the number of women with high grade serous ovarian cancer who are being screened in Princess Margaret Cancer Center for mutations in BRCA1/2
  • To track accrual rates and clinical outcomes in patients with high grade serous ovarian cancer who are BRCA1/2-positive
  • To correlate impact of BRCA1/2 mutational status on clinical outcome
  • To track utilization of genetic counseling services at Princess Margaret Cancer Centre

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome.
Study Start Date : May 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources


Intervention Details:
    Genetic: BRCA genetic data
    Two blood samples will be taken which is part of the standard of care. Tumor samples will be obtained from previous biopsy or surgery prior to this study for DNA testing


Primary Outcome Measures :
  1. genomic profiling for BRCA1 and BRCA2 mutational status in patients' with high grade serous ovarian cancer. [ Time Frame: upon availability of genetic consultation report min 6 weeks ]
    participants will also be followed for all treatments and responses until death



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with high grade serous carcinoma originating from the ovaries, fallopian tube or peritoneal cavity; subtype of high grade endometrioid and clear cell ovarian cancer could be eligible in the exploratory cohort
Criteria

Inclusion Criteria:

  • Patients with high grade serous carcinoma originating from the ovaries, fallopian tube or peritoneal cavity; subtype of high grade endometrioid and clear cell ovarian cancer could be eligible in the exploratory cohort
  • Patient must be ≥18 years old
  • All patients must have sufficient archival tumor tissue for molecular analysis
  • All patients must consent to have a genetic testing
  • All patients must have signed and dated an informed consent form

Exclusion Criteria:

· Other histology subtype


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): NCT02341118


Contacts
Contact: David Gutierrez 416-946-4501 ext 4821 David.Gutierrez@uhn.ca

Locations
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Amit Oza    416-946-2818      
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Amit Oza University Health Network, Toronto

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02341118     History of Changes
Other Study ID Numbers: BRCA Screening
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by University Health Network, Toronto:
BRCA1/2 Mutational Status

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders