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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. (see Contacts and Locations)
Verified April 2014 by University of Washington
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
Information provided by (Responsible Party):
Elizabeth Swisher, University of Washington
ClinicalTrials.gov Identifier:
NCT01167842
First received: July 20, 2010
Last updated: April 8, 2014
Last verified: April 2014
  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 University of Washington:

Primary Outcome Measures:
  • Analysis of Inherited Cancers [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

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 2014
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Elizabeth M Swisher, MD University of Washington
  More Information

No publications provided

Responsible Party: Elizabeth Swisher, Associate Professor, Obstetrics & Gynecology, University of Washington
ClinicalTrials.gov Identifier: NCT01167842     History of Changes
Other Study ID Numbers: 7016, P50CA083636
Study First Received: July 20, 2010
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Breast Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 23, 2014