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

NCT07401316 | Recruiting DMC FDA Device

• 1 other identifier: CTO-IUSCCC-0937
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Keywords

ctDNA

Outcome Measures

Primary Outcomes (3)

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

  PPV will be calculated as the number of true positives divided by the total number of positive tests in patients with high-risk stage I germ cell tumor.

  At screening and every 4 months up to 2 years

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

  PPV will be calculated as the number of true positives divided by the total number of positive tests in the node dissection patients with clinical stage II germ cell tumor.

  At screening and every 4 months up to 2 years

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

  PPV will be calculated as the number of true positives divided by the total number of positive tests in the first-line chemotherapy patients with clinical stage III germ cell tumor.

  At screening and every 4 months up to 2 years

Secondary Outcomes (5)

• Negative predictive value (NPV) of circulating tumor DNA in Cohort I

  At screening and every 4 months up to 2 years

• Negative predictive value (NPV) of circulating tumor DNA in Cohort II

  At screening and every 4 months up to 2 years

• Negative predictive value (NPV) of circulating tumor DNA in Cohort III

  At screening and every 4 months up to 2 years

• Post-node dissection circulating tumor DNA bioassay

  At screening and every 4 months up to 2 years

• Post-node dissection clearance rate of ctDNA

  At screening and every 4 months up to 2 years

Study Arms (3)

Cohort I - High Risk Clinical stage I

EXPERIMENTAL

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.

Diagnostic Test: Whole blood for ctDNA

Cohort II- Clinical stage II

EXPERIMENTAL

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.

Diagnostic Test: Whole blood for ctDNA

Cohort III- Clinical stage III

EXPERIMENTAL

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.

Diagnostic Test: Whole blood for ctDNA

Interventions

Whole blood for ctDNA DIAGNOSTIC_TEST

Whole blood for ctDNA

Cohort I - High Risk Clinical stage I; Cohort II- Clinical stage II; Cohort III- Clinical stage III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Natera, Inc.: collaborator

Study Sites (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Study Officials

• Nabil Adra, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marietta Moore, RN

CONTACT

317-274-7477; marlmoor@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

US (1)