Identifying and Caring for Individuals With Inherited Cancer Syndrome
Recruiting · NCT04494945 · Interventional (participants receive a specific treatment) · Lead sponsor: OHSU Knight Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionGenetic CounselingGenetic TestingSurvey Administration
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- Providence Portland Medical Center - Portland, Oregon, United States
- OHSU Knight Cancer Institute - Portland, Oregon, United States