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Genetic Testing for Inherited Cancer Risk

N/A
Recruiting
Led By Paul T Spellman, Ph.D.
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ALL COHORTS: 18 years of age or older
COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial offers free genetic testing to the public to learn the value of testing for high risk cancer types.

Who is the study for?
This trial is for adults who may or may not have cancer but are interested in genetic testing for inherited cancer syndromes like BRCA1, BRCA2, and Lynch syndrome. It's open to those who've had genetic counseling within the last five years or an encounter within the past year. Participants need to consent and create a secure account for data collection.
What is being tested?
The study offers free genetic testing to the public and collects biospecimens. It includes surveys and genetic counseling to understand the benefits of widespread testing for hereditary cancers versus only high-risk families.
What are the potential side effects?
Since this trial involves non-invasive procedures like surveys, specimen collection, and counseling rather than drug treatments, it does not pose typical medication side effects. However, learning about one's genetic risks can have emotional or psychological impacts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have genetic mutations in BRCA1, BRCA2, or Lynch syndrome.
Select...
I have been diagnosed with a type of cancer that is tracked by the National Cancer Institute, including early-stage breast cancer.
Select...
I have genetic variants like BRCA1, BRCA2, or Lynch syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes
Cascade screening rate among Lynch or HBOC positive carriers
Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Screening (genetic testing)Experimental Treatment4 Interventions
Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
236 Previous Clinical Trials
2,062,072 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,085,080 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
1,008 Previous Clinical Trials
7,386,809 Total Patients Enrolled
Paul T Spellman, Ph.D.Principal Investigator - OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
Jackilen Shannon, Ph.D.Principal InvestigatorOHSU Knight Cancer Institute

Media Library

Screening (genetic testing) Clinical Trial Eligibility Overview. Trial Name: NCT04494945 — N/A
Neoplastic Syndromes Research Study Groups: Screening (genetic testing)
Neoplastic Syndromes Clinical Trial 2023: Screening (genetic testing) Highlights & Side Effects. Trial Name: NCT04494945 — N/A
Screening (genetic testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04494945 — N/A
~2183 spots leftby Jun 2025
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