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

Breast Cancer Clinical Trial

Official title:

Analysis of Inherited Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167842
• Other study ID #: 7016
• Secondary ID: P50CA083636
• Status: Completed
• Start date: October 2009
• Est. completion date: January 14, 2022

Study information

• Verified date: February 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 14, 2022
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Ovarian Cancer

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Fred Hutchinson Cancer Research Center, National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of Inherited Cancers		up to 10 years