A Registry to Collect Patient and Family DNA and Information for Anyone who has had Multiplex Testing and Gene Mutation Results

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-003372
    NCT ID: NCT02665195
    Sponsor Protocol Number: 16-003372

About this study

The purpose of this study is to collect patient and family DNA and disease data to learn more about how changes in certain genes may be linked to cancer. Some people with cancer may have aquired their disease because they inherited an abnormal (mutated) gene. The researchers of this study want to better understand the risks that are linked to genetic changes in these less well-studied genes. By understanding these risks, it is believed that doctors will be able to give better advice to families with mutations in these genes.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Has deleterious (pathogenic) or likely deleterious (likely pathogenic) mutation in a cancer susceptibility gene
  • Has a variant of uncertain significance (VUS) in a cancer susceptibility gene
  • Is a tested or untested member of a family known to be transmitting a deleterious or likely deleterious mutation or a variant of uncertain significance in a cancer predisposition gene 
  • Followed up for study within 6 weeks

Exclusion Criteria

  • Inability or refusal to participate in consent discussion
  • Is less than 18 years old

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Fergus Couch, Ph.D.

Open for enrollment

Contact information:

Tricia Harstad

(855)511-3952

rstbreaststudies@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20258287

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