Germline genetic testing for cancer risk in patients with solid tumors
Prospective Community Cancer Clinics-based Approach to Optimize Germline Testing in Cancer Patients in Rural Setting to Address Racial Disparities: UNIversal Germline Testing in the communitY (UNITY) Study
This study is testing whether genetic testing can help adults with solid tumor cancers understand their risk of cancer and how it might affect their care over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Invitae Corporation Industry-sponsored |
| Locations | 1 site (Rock Hill, South Carolina) |
| Trial ID | NCT05416710 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enroll adult participants diagnosed with solid tumor cancers to undergo germline genetic testing for cancer risk using Invitae's Multi-Cancer gene panel. Participants will provide blood samples for both clinical testing and future research, along with tumor samples from prior procedures. Clinicians will submit relevant medical history and demographic data at three intervals: one month, one year, and two years after genetic testing results are received. The study seeks to gather comprehensive data to better understand the implications of genetic testing in cancer risk assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histologically confirmed diagnosis of a solid tumor cancer who consent to genetic testing.
Not a fit: Patients with hematologic malignancies or those unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cancer risk assessment and inform personalized treatment strategies for patients with solid tumors.
How similar studies have performed: Other studies utilizing germline genetic testing in cancer patients have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient has consented to germline genetic testing * Patient has a histologically confirmed diagnosis of a solid tumor cancer * Patient is willing to release previously collected tissue sample * Patient is willing to provide research blood samples * Patient must be at least 18 years of age Exclusion Criteria: * Patient is unable to consent. * Patient with hematologic malignancy
Where this trial is running
Rock Hill, South Carolina
- Carolina Blood and Cancer Care Associates, PA' — Rock Hill, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Lee Ifhar
- Email: lee.ifhar@invitae.com
- Phone: 5512150508
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.