Capturing BRCA1/2 Mutational Status in Women With High Gr... | NCT02341118

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

NCT02341118

Sponsor

University Health Network, Toronto

Status

Terminated

Last Update Posted

Jul 27, 2023Actual

Enrollment

109Actual

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

BRCA genetic data

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study did not collect sufficient data for primary endpoint analysis.

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Apr 2018Actual

Completion Date

May 8, 2023Actual

First Submitted Date

Nov 27, 2014

First Submission Date that Met QC Criteria

Jan 13, 2015

First Posted Date

Jan 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2023

Last Update Posted Date

Jul 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BRCA genetic data	Genetic	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amit Oza	University Health Network, Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Princess Margaret Cancer Centre		Toronto	Ontario		Canada

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

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Browse Branches

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