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

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ClinicalTrials.gov Identifier: NCT01167842
Recruitment Status : Recruiting
First Posted : July 22, 2010
Last Update Posted : November 1, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Breast Cancer Ovarian Cancer

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.

Study Design

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of Inherited Cancers
Study Start Date : October 2009
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Analysis of Inherited Cancers [ Time Frame: up to 10 years ]

Biospecimen Retention:   Samples With DNA
We will collect blood as a source for DNA from lymphocytes as well as tumor blocks as a source for tumor DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic, Cancer center, University medical center

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
Contacts and Locations

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): NCT01167842

Contact: Kathy J Agnew, BS 206-685-7927 kagnew@u.washington.edu

United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Kathy J Agnew, BS    206-685-7927    kagnew@u.washington.edu   
Principal Investigator: Elizabeth M Swisher, MD         
Sponsors and Collaborators
University of Washington
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Fred Hutchinson Cancer Research Center
Principal Investigator: Elizabeth M Swisher, MD University of Washington
More Information

Responsible Party: Elizabeth Swisher, Associate Professor, Obstetrics & Gynecology, University of Washington
ClinicalTrials.gov Identifier: NCT01167842     History of Changes
Other Study ID Numbers: 7016
P50CA083636 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016