Analysis of Tumors From Patients With Inherited Cancers Having Had Two Surgeries (Primary + Recurrent, or 2 Separate Types of Cancer)

NCT ID: NCT01167842

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2022-01-14

Brief Summary

This study will analyze tumor tissue from patients with known genetic mutations (BRCA1, BRCA2, CHK2, etc) who have tumor tissue available from two surgeries, either primary/recurrent, or two different anatomical sites.

Detailed Description

This study will recruit individuals with known BRCA1 and BRCA2 mutations or mutations in similar cancer causing genes such as CHK2 or PALB2 who have had a cancer removed by surgery or biopsied two or more times with available pathological blocks. We wish to enroll individuals who have had more than one surgery or biopsy for cancer allowing us to obtain tumor blocks from more than one time point. Such patients would include those with one cancer which has recurred or more than one separate cancer. We will conduct a brief interview with the subject to obtain personal information about medical and treatment history. In addition, we will collect clinical information from their treating physician(s) to correlate molecular findings with clinical responses to treatment and survival and recurrence data. We will collect background clinical information and family history information and a copy of the genetic test results documenting their cancer causing mutation. We will recruit only patients with known BRCA1 or BRCA2 mutations or known mutations in other cancer causing genes such as CHK2 or PALB2 and will not perform genetic testing on non-tumor tissue for any new information on genetic susceptibility in patient samples. Enrolled subjects will donate a blood sample that will be obtained locally and shipped to the research laboratory, and this cost will be entirely covered by the research group.

Conditions

Breast Cancer; Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Male or female
• Age 18 or older
• documented mutation in BRCA1, BRCA2 or other known cancer causing gene
• one or more cancer with available stored tissue blocks or slides
• willing to donate 16cc of blood
• able to understand English and provide informed consent

Exclusion Criteria

• unable or unwilling to provide informed consent
• patient does not have tissue blocks available
• minor, under age 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Swisher

Associate Professor, Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth M Swisher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

P50CA083636

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7016

Identifier Type: -

Identifier Source: org_study_id