Recruiting

Genetic Testing

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT04494945

Conditions

BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome

Breast Ductal Carcinoma In Situ

Hematopoietic and Lymphoid System Neoplasm

Hereditary Neoplastic Syndrome

Lynch Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Genetic Counseling

Genetic Testing

Survey Administration

Study Details

Brief 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.

Conditions

BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome

Breast Ductal Carcinoma In Situ

Hematopoietic and Lymphoid System Neoplasm

Hereditary Neoplastic Syndrome

Lynch Syndrome

Study ID

NCT04494945

Start date

Mar 9, 2020

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

27500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Screening (genetic testing)

Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.

Interventions

Biospecimen Collection

Undergo collection of saliva sample

Genetic Counseling

Receive genetic counseling if testing results are positive

Genetic Testing

Undergo genetic testing

Survey Administration

Complete a survey

Primary outcome measure

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

Central Contacts and Locations

Locations

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Bill J. Wright, Ph.D.

Bill.Wright@providence.org

Principal Investigator:

Bill J. Wright, Ph.D.

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jackilen Shannon, Ph.D.

503-494-4993shannoja@ohsu.edu

Principal Investigator:

Jackilen Shannon, Ph.D.

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Jul 14, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-07-14.