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

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.

Study Overview

• Status: Recruiting
• Conditions: Germ Cell Cancer Metastatic
• Intervention / Treatment: Diagnostic test: Whole blood for ctDNA

Detailed Description

This is a specimen collection study where patients with high-risk stage I germ cell tumor, clinical stage II germ cell tumor, and clinical stage III germ cell tumor will be evaluated for ctDNA.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen Moore, BA; Phone Number: 317-274-0930; Email: kaelmoor@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
      • Principal Investigator: Nabil Adra, MD
      • Contact: Kathleen Moore, BA; Phone Number: 317-274-0930; Email: kaelmoor@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Eligible patients have been diagnosed with either high-risk stage I or clinical stage II germ cell tumors (GCT) and are planning to receive standard of care (SOC) treatment; including either an orchiectomy (a surgical procedure that removes one or both testicles) for stage I, or a retroperitoneal lymph node dissection (RPLND) (surgery to remove the lymph nodes in the back of the abdomen).

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: Whole blood for ctDNA; Whole blood for ctDNA
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.	Diagnostic test: Whole blood for ctDNA; Whole blood for ctDNA
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.	Diagnostic test: Whole blood for ctDNA; Whole blood for ctDNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative predictive value (NPV) of circulating tumor DNA in Cohort I	NPV will be calculated as the number of true negatives divided by the total number of negative tests in patients with high-risk stage I germ cell tumor.	At screening and every 4 months up to 2 years
Negative predictive value (NPV) of circulating tumor DNA in Cohort II	NPV will be calculated as the number of true negatives divided by the total number of negative tests in the node dissection patients with clinical stage II germ cell tumor.	At screening and every 4 months up to 2 years
Negative predictive value (NPV) of circulating tumor DNA in Cohort III	NPV 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
Post-node dissection circulating tumor DNA bioassay	Means/stds of ctDNA in both the relapsed and non-relapsed patients in Cohort II.	At screening and every 4 months up to 2 years
Post-node dissection clearance rate of ctDNA	The clearance rate of ctDNA in the node dissection patients in Cohort II.	At screening and every 4 months up to 2 years

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Natera, Inc.
• Investigators: Principal Investigator: Nabil Adra, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ctDNA
• Other Study ID Numbers: CTO-IUSCCC-0937

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes