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Wednesday, June 22, 2016

Cancer Genetics Hereditary Cancer Panel Testing - Full Text View - ClinicalTrials.gov



ClinicalTrials.gov
refer to this study by its ClinicalTrials.gov identifier: 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.

Condition Intervention
Hereditary Breast and Ovarian Cancer
Other: Questionnaires
Other: Blood Draw and Baseline Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: University of Southern California (USC) Norris Comprehensive Cancer Center and Stanford Cancer Institute Cancer Genetics Hereditary Cancer Panel Testing
Criteria
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

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