Analysis of Tumors From Patients With Inherited Cancers Having Had Two Surgeries (Primary + Recurrent, or 2 Separate Types of Cancer)
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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 |
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) |
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 |
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| 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 | |
| Principal Investigator: | Elizabeth M Swisher, MD | University of Washington |
More Information
No publications provided
| Responsible Party: | Elizabeth Swisher, MD, University of Washington |
| ClinicalTrials.gov Identifier: | NCT01167842 History of Changes |
| Other Study ID Numbers: | 7016, P50CA083636 |
| Study First Received: | July 20, 2010 |
| Last Updated: | August 6, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Ovarian Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Endocrine Gland Neoplasms |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 16, 2013