Cancer Genetics Hereditary Cancer Panel Testing

Recruiting

I'm Interested

Trial ID: NCT02324062

Purpose

This study is about understanding the use of a genetic test (Myriad Genetics myRisk panel) that analyzes 25 genes related to different hereditary cancer conditions. The investigators hope to learn more about how this type of genetic test is used clinically. The investigators also hope to understand more about the experience of individuals and families who undergoing this test of genetic testing.

Official Title

University of Southern California (USC) Norris Comprehensive Cancer Center and Stanford Cancer Institute Cancer Genetics Hereditary Cancer Panel Testing

Stanford Investigator(s)

Allison W. Kurian, M.D., M.Sc.
Allison W. Kurian, M.D., M.Sc.

Professor of Medicine (Oncology) and of Epidemiology and Population Health

Uri Ladabaum
Uri Ladabaum

Professor of Medicine (Gastroenterology and Hepatology)

Eligibility


Inclusion Criteria:Screening Criteria Patients meeting one of the following criteria will
be eligible for screening the study.

   - Any individual with multiple primary cancers

   - Any individual diagnosed with cancer under age 50

   - Individuals with two or more first or second-degree relatives with cancer.

   - Individuals from families where at least one family member was diagnosed with cancer
   under age 50

   - Individuals meeting a phenotypic diagnosis of specific hereditary cancer syndromes
   including, but not limited to:

      - Hereditary Breast and Ovarian Cancer

      - Lynch Syndrome

      - Familial or Attenuated Adenomatous Polyposis Syndrome

      - Hereditary Melanoma Syndrome

      - Hereditary Pancreatic Syndrome

      - Li Fraumeni Syndrome

      - Cowden Syndrome

      - Hereditary Diffuse Gastric Cancer

      - Peutz Jeghers Syndrome

      - Juvenile Polyposis Syndrome

      - Ataxia Telangiectasia (Louis-Bar syndrome)

Individuals with a pretest mutation probability of > 2.5% based on validated published
models 15

   - Mismatch Repair (MMR)pro

   - Prediction model for mutL homolog 1 (MLH1), muS homolg 2 (MSH2), and mutS homolog 6
   (MSH6) gene mutations (Premm 1,2,6)

   - Pancreas (Panc)Pro

   - Melanoma (Mela)Pro

   - Breast cancer (BRCA)Pro

   - Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm
   (BOADICEA)

   - International Breast Cancer Intervention Study (IBIS) (Tyler-Cuzick)

   - Myriad II

   - Phosphatase and tensin homolog (PTEN) Cleveland Clinic Score

   - Clinical probability of > 2.5% where models are not available

Or one of the following:

Individuals with a phenotypic diagnosis of the following recognized cancer genetic
syndromes which automatically confers a clinical chance of > 2.5%:

   - Hereditary Breast and Ovarian Cancer

   - Lynch Syndrome

   - Familial or Attenuated Adenomatous Polyposis Syndrome

   - Hereditary Melanoma Syndrome

   - Hereditary Pancreatic Syndrome

   - Li Fraumeni Syndrome

   - Cowden Syndrome

   - Hereditary Diffuse Gastric Cancer

   - Peutz Jeghers Syndrome

   - Juvenile Polyposis Syndrome

   - Ataxia Telangiectasia (Louis-Bar syndrome) Participation will be open to patients of
   both sexes, all races and ethnic backgrounds, and of all ages. Subjects will include
   healthy individuals, cancer survivors, and patients actively being treated for cancer.
   Individuals at-risk for a hereditary cancer syndrome under age 18 will eligible for
   HCP testing if they meet the eligibility criteria with written parental consent and
   child assent where appropriate. Cognitively impaired adult subjects will be invited to
   participate through the written, informed consent of a legal representative designated
   on the consent form.

Exclusion Criteria:

Patients meeting one of the following criteria will be excluded the study

   - Individuals with a pretest mutation probability of < 2.5% based on validated published
   models

   - Prior genetic testing for germline cancer susceptibility

   - Inability to provide written informed consent

Intervention(s):

other: Questionnaires

other: Blood Draw and Baseline Questionnaire

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
James Ford, MD
650-498-6689