Recruiting

Identifying and Caring for Individuals With Inherited Cancer Syndrome

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.

ClinicalTrials.gov IDNCT04494945

PhaseNA

Enrollment27500

SponsorOHSU Knight Cancer Institute

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphoid System Neoplasm, Hereditary Neoplastic Syndrome, Lynch Syndrome, Malignant Solid Neoplasm

About this study

Interventions

Procedure: Biospecimen Collection — Undergo collection of saliva sample
Other: Genetic Counseling — Receive genetic counseling if testing results are positive
Other: Genetic Testing — Undergo genetic testing
Other: Survey Administration — Complete a survey

Primary outcomes

Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations (Up to 5 years)
Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes (Up to 5 years)
Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging (Up to 5 years)
Cascade screening rate among Lynch or HBOC positive carriers (Up to 5 years)

Eligibility information

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 signature * COHORT C: Consent to the HOP repository, either hard or electronic signature * COHORT C: Choosing to submit a DNA sample

Study locations

Providence Portland Medical Center, Portland, Oregon 97213 United States
OHSU Knight Cancer Institute, Portland, Oregon 97239 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-20.