A blood test to find tumor DNA in adults with high‑risk or advanced germ‑cell tumors
Circulating Tumor DNA in Stage I, II, and III Germ-Cell Tumors
We are testing whether a blood test (ctDNA) can detect leftover cancer cells after treatment in adults with high‑risk stage I through stage III germ‑cell tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07401316 on ClinicalTrials.gov |
What this trial studies
This is a specimen collection protocol that takes whole blood to look for circulating tumor DNA (ctDNA) in adults with high‑risk stage I, clinical stage II, or clinical stage III/IS germ‑cell tumors. Participants must have histologic or serologic confirmation of seminomatous or non‑seminomatous germ‑cell tumor and available archival tumor tissue. Blood samples will be processed for ctDNA analysis in collaboration with a commercial partner, and results will be compared with clinical and pathologic data to develop a post‑treatment detection tool. The study is conducted at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center.
Who should consider this trial
Good fit: Adults (≥18) with confirmed seminomatous or non‑seminomatous germ‑cell tumors who are classified as high‑risk stage I, stage II, or stage III/IS and can provide archival tissue and informed consent are ideal candidates.
Not a fit: Patients without germ‑cell tumors, those judged low‑risk stage I, those who cannot provide archival tissue or informed consent, or those unable to travel to the study center are unlikely to benefit.
Why it matters
Potential benefit: If successful, the ctDNA test could identify residual cancer earlier than current methods and help personalize follow‑up and treatment decisions.
How similar studies have performed: ctDNA monitoring has shown promise in other cancers, and early limited work in germ‑cell tumors is encouraging though not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Subjects must have histologically or serologically confirmed seminomatous or non seminomatous germ cell tumor. Non-seminoma includes embryonal carcinoma, choriocarcinoma, yolk sac tumor, or teratoma. Note: Cohort I is for high-risk clinical stage I disease (high risk will be defined as per enrolling investigator discretion). Cohort II is for clinical stage II. Cohort III is for clinical stage III or IS. 4. Archival tissue for germ-cell tumor diagnosis available Exclusion Criteria: 1. Concurrent disease or condition that would make the subject inappropriate for study participation 2. Any serious medical disorder that would interfere with the subject's safety 3. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent per treating physician coverage. 4. Patient is being tested for minimal residual disease with other experimental platforms
Where this trial is running
Indianapolis, Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Nabil Adra, MD — Indiana University
- Study coordinator: Kathleen Moore, BA
- Email: kaelmoor@iu.edu
- Phone: 317-274-0930
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.