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OpenTrials
Completed

NCT Number: NCT01167842

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Analysis of Inherited Cancers

    Time frame: up to 10 years

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Fred Hutchinson Cancer Center
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Analysis of Inherited Cancers

Important dates

Study start
2009
Primary completion
2021
Study completion
2022
First posted
Jul 22, 2010
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.