RecruitingNot Applicable

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

United States130 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥ 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.
✓. Archival tissue for germ-cell tumor diagnosis available

Exclusion criteria

✕. 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

What they're measuring

Positive predictive value (PPV) of circulating tumor DNA in Cohort I

Timeframe: At screening and every 4 months up to 2 years

Positive predictive value (PPV) of circulating tumor DNA in Cohort II

Timeframe: At screening and every 4 months up to 2 years

Positive predictive value (PPV) of circulating tumor DNA in Cohort III

Timeframe: At screening and every 4 months up to 2 years

Trial details

NCT IDNCT07401316

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2032-12

Contact for this trial

Kathleen Moore, BA

317-274-0930 kaelmoor@iu.edu

View on ClinicalTrials.gov More Germ Cell Cancer Metastatic trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥ 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.
✓. Archival tissue for germ-cell tumor diagnosis available

Exclusion criteria

✕. 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

What they're measuring

Positive predictive value (PPV) of circulating tumor DNA in Cohort I

Timeframe: At screening and every 4 months up to 2 years

Positive predictive value (PPV) of circulating tumor DNA in Cohort II

Timeframe: At screening and every 4 months up to 2 years

Positive predictive value (PPV) of circulating tumor DNA in Cohort III

Timeframe: At screening and every 4 months up to 2 years