RecruitingNot Applicable

Identifying and Caring for Individuals With Inherited Cancer Syndrome

United States27,500 participantsStarted 2020-03-09

Plain-language summary

This trial examines approaches to identify and care for individuals with inherited cancer syndrome. The purpose of this study is to offer no cost genetic testing to the general public. Researchers hope to learn the value of providing broad, public-wide testing for high risk cancer types (like hereditary breast and ovarian cancer or Lynch syndromes) instead of only testing people whose families are known to be high risk.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ALL COHORTS: 18 years of age or older * Retrospective COHORT A: Per HIPAA waiver, Retrospective Cohort A will not actively consent * Retrospective COHORT A: Patients may or may not be diagnosed with cancer * Retrospective COHORT A: Patients have received genetic counseling in the past 5 years * Retrospective COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome * COHORT A: Per Health Insurance Portability and Accountability Act (HIPAA) waiver, Cohort A returns survey as consent * COHORT A: Patients may or may not be diagnosed with cancer * COHORT A: Patients have received genetic counseling in the past 1 - 2 years * COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome * COHORT A: INCLUSIVE of no contact list to exclude from Cohort B * COHORT B: Creation of secure Healthy Oregon Project (HOP) app account * COHORT B: Consent to this project, either hard or electronic signature * COHORT B: Consent to the HOP repository, either hard or electronic signature * COHORT B: Choosing to submit a deoxyribonucleic acid (DNA) sample * COHORT B: Patients diagnosed with any National Cancer Institute (NCI)-reportable cancers, including ductal carcinoma in situ (DCIS) and/or in situ breast cancer * COHORT B: Must have had an encounter within past twelve months * COHORT B: Exclude Cohort A * COHORT C: Creation of secure Hop app account * COHORT C: Consent to this project, either hard or electronic sign…

What they're measuring

Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations

Timeframe: Up to 5 years

Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes

Timeframe: Up to 5 years

Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging

Timeframe: Up to 5 years

Cascade screening rate among Lynch or HBOC positive carriers

Timeframe: Up to 5 years

Trial details

NCT IDNCT04494945

SponsorOHSU Knight Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations

Timeframe: Up to 5 years

Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes

Timeframe: Up to 5 years

Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging

Timeframe: Up to 5 years

Cascade screening rate among Lynch or HBOC positive carriers

Timeframe: Up to 5 years