RecruitingNot ApplicableNCT07401316
Circulating Tumor DNA in Stage I, II, and III Germ-Cell Tumors
Sponsor
Indiana University
Enrollment
130 participants
Start Date
Jun 3, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
This study will evaluate the utility of ctDNA detection in patients with high-risk stage I, stage II, and stage III germ cell tumor disease to develop a tool for post-treatment cancer cell detection.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- 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.
- Archival tissue for germ-cell tumor diagnosis available
Exclusion Criteria4
- Concurrent disease or condition that would make the subject inappropriate for study participation
- Any serious medical disorder that would interfere with the subject's safety
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent per treating physician coverage.
- Patient is being tested for minimal residual disease with other experimental platforms
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Interventions
DIAGNOSTIC_TESTWhole blood for ctDNA
Whole blood for ctDNA
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07401316