Clinical trial Recruiting at 1 site Interventional Ages 18 and up

A blood test to find tumor DNA in adults with high‑risk or advanced germ‑cell tumors

Official title: Circulating Tumor DNA in Stage I, II, and III Germ-Cell Tumors

Run by Indiana University · NCT07401316 · Data updated 2026-11-12

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.

More Germ Cell Cancer Metastatic trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment130 (estimated)
SponsorIndiana University
Academic / other
Locations1 site (Indianapolis, Indiana)
StatusRecruiting
StartedJune 3, 2026
Main results expectedDecember 2032
Study endsDecember 2032
Registry record updatedJune 15, 2026
Trial IDNCT07401316 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: ctDNA monitoring has shown promise in other cancers, and early limited work in germ‑cell tumors is encouraging though not yet definitive.

Who can join: the full rules

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 it's running

  • 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: Marietta Moore, RN
  • Email: marlmoor@iu.edu
  • Phone: 317-274-7477

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.