Large study looks at how a 25-Gene cancer test affects patients and families
NCT ID NCT02324062
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how a genetic test that checks 25 genes linked to hereditary cancers is used in clinics. Over 1,500 people with a personal or family history of cancer took part. Researchers collected blood samples and had participants fill out questionnaires over five years to learn about their experiences and how the test results affected their care.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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1,511 people
The number who actually took part.
- Started
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Jun 2014
- Finished
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Aug 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
High-risk cancer genetics populations. Both male and female participants will be recruited.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Stanford University
Stanford, California, 94305, United States
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University of Southern California/ Kenneth Norris, Jr. Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181, United States
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Other studies related to the condition(s) this trial covers.
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