Lynch Syndrome Clinical Trials

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Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes

Who is this study for? Adult patients with Hereditary Breast Cancer, Ovarian Cancer, or Lynch Syndrome
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Oregon
OHSU Knight Cancer Institute
RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Time Frame
Start Date: 2020-03-09
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 27500
Treatments
Other: Screening (genetic testing)
Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
Authors
Paul T. Spellman
Sponsors
Leads: OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov