Genetic testing for young adults with cancer
Randomized Trial of Universal vs. Guideline-directed Germline Testing Among Young Adults With Cancer
This study is testing whether universal genetic testing can help young adults with cancer find hidden genetic risks and improve care for their family members.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1238 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04533555 on ClinicalTrials.gov |
What this trial studies
This research aims to establish a sustainable method for identifying and managing genetic risks in young adults diagnosed with cancer. It will involve a randomized trial where participants will undergo universal genetic testing to uncover germline cancer risks that may be overlooked by traditional testing methods. The study will also assess the impact of this testing on the relatives of patients, aiming to improve adherence to risk reduction strategies. Participants will be randomly assigned to either the experimental group receiving genetic testing or a control group, with outcomes measured over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 18-39 diagnosed with a solid tumor within the past year.
Not a fit: Patients with in situ cancer, certain types of leukemia, or those who have already undergone genetic testing for their cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier identification of genetic risks in young adults with cancer, potentially improving their treatment and preventive care.
How similar studies have performed: Previous studies have shown promise in using universal genetic testing approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients will be eligible if they meet the following criteria: * Diagnosed with a solid tumor between age 18-39 (patients may be 40 years of age at time of enrollment) * Within one year of diagnosis with index cancer * Have had at least two visits at Penn Medicine for the cancer diagnosis (to exclude one-time second opinions) Exclusion Criteria: Patients will be excluded if they meet any of the following criteria: * Diagnosis of in situ cancer, thyroid cancer (papillary or follicular), or leukemia Breast cancer diagnosis (aim 1 only) * Have a known genetic predisposition to cancer * Underwent genetic testing after this cancer diagnosis * Have a benign neoplasm
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Katherine L Nathanson, MD — University of Pennsylvania
- Study coordinator: Benita Weathers, MPH
- Email: weathers@upenn.edu
- Phone: 215-573-8860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.