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

This study is currently recruiting participants.
Verified October 2016 by Elizabeth Swisher, University of Washington
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167842
First Posted: July 22, 2010
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
Elizabeth Swisher, University of Washington
  Purpose
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
Breast Cancer Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Analysis of Inherited Cancers

Resource links provided by NLM:


Further study details as provided by Elizabeth Swisher, University of Washington:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 150
Study Start Date: October 2009
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
  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


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

Locations
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
Investigators
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 Submitted: July 20, 2010
First Posted: July 22, 2010
Last Update Posted: November 1, 2016
Last Verified: October 2016