Recruiting

ctDNA Detection

Sponsor:

Indiana University

Code:

NCT07401316

Conditions

Germ Cell Cancer Metastatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Whole blood for ctDNA

Study Details

Brief 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.

Conditions

Germ Cell Cancer Metastatic

Study ID

NCT07401316

Start date

Jun 3, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort I - High Risk Clinical stage I

50 subjects will be enrolled with high-risk stage I seminomatous or non-seminomatous germ cell tumors. In these patients, ctDNA will be collected post-orchiectomy prior to initiation of surveillance and every 4 months during surveillance for up to 2 years.

experimental: Cohort II- Clinical stage II

30 patients will be enrolled with clinical Stage II seminomatous or non-seminomatous germ cell tumor who are planning to undergo primary resection with RPLND. In these patients, ctDNA will be collected prior to surgery and every 4 months after surgery for up to 2 years.

experimental: Cohort III- Clinical stage III

50 patients will be enrolled with clinical Stage III (or IS) seminomatous or non-seminomatous germ cell tumor who are planning to undergo first-line chemotherapy. In these patients, ctDNA will be collected prior to chemotherapy, at cycle 2 day 1, within 28 days of starting last cycle of chemotherapy, and every 4 months after completing chemotherapy.

Interventions

Whole blood for ctDNA

Whole blood for ctDNA

Primary outcome measure

  • Positive predictive value (PPV) of circulating tumor DNA in Cohort I [ Time Frame: At screening and every 4 months up to 2 years ]
  • Positive predictive value (PPV) of circulating tumor DNA in Cohort II [ Time Frame: At screening and every 4 months up to 2 years ]
  • Positive predictive value (PPV) of circulating tumor DNA in Cohort III [ Time Frame: At screening and every 4 months up to 2 years ]

Central Contacts and Locations

Central contacts

Marietta Moore, RN

317-274-7477marlmoor@iu.edu

Locations

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Marietta Moore, RN

317-274-7477kaelmoor@iu.edu

Principal Investigator:

Nabil Adra, MD

More Information

Sponsor

Indiana University

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • ctDNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-06-15.