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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreTrial 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 2
~1720
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
231 Previous Clinical Trials
2,063,163 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,905,229 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
978 Previous Clinical Trials
7,358,920 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have genetic mutations in BRCA1, BRCA2, or Lynch syndrome.I am willing to provide a DNA sample.You have received genetic counseling within the past 5 years.I may or may not have been diagnosed with cancer.I have been diagnosed with a type of cancer that is tracked by the National Cancer Institute, including early-stage breast cancer.I have genetic variants like BRCA1, BRCA2, or Lynch syndrome.I choose to provide a DNA sample.I may or may not have a cancer diagnosis.I have had genetic counseling in the last 1-2 years.I have seen a doctor or been in a hospital within the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Screening (genetic testing)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current total of participants in this experiment?
"Indeed, the information on clinicaltrials.gov indicates that recruitments are in progress for this trial which was initially posted by 3rd of September 2020 and lately modified on 15th of September 2022. The research requires 27500 participants from two distinct sites."
Answered by AI
Are there opportunities for patients to participate in this experiment at present?
"Correct. According to the clinicaltrials.gov website, this medical experiment is still actively recruiting patients who meet certain criteria; it was initially published on March 9th 2020 and has since been updated as recently as September 15th 2022. A total of 27,500 participants are needed at two different sites for the trial to be successful."
Answered by AI
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