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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07401316

Enrollment

130

Registered

2026-02-10

Start date

2026-06-03

Completion date

2032-12-01

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Germ Cell Cancer Metastatic

Keywords

ctDNA

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.

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.

Interventions

DIAGNOSTIC_TESTWhole blood for ctDNA

Whole blood for ctDNA

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Positive predictive value (PPV) of circulating tumor DNA in Cohort I	At screening and every 4 months up to 2 years	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.
Positive predictive value (PPV) of circulating tumor DNA in Cohort II	At screening and every 4 months up to 2 years	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.
Positive predictive value (PPV) of circulating tumor DNA in Cohort III	At screening and every 4 months up to 2 years	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.

Secondary

Measure	Time frame	Description
Negative predictive value (NPV) of circulating tumor DNA in Cohort I	At screening and every 4 months up to 2 years	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.
Negative predictive value (NPV) of circulating tumor DNA in Cohort II	At screening and every 4 months up to 2 years	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.
Negative predictive value (NPV) of circulating tumor DNA in Cohort III	At screening and every 4 months up to 2 years	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.
Post-node dissection circulating tumor DNA bioassay	At screening and every 4 months up to 2 years	Means/stds of ctDNA in both the relapsed and non-relapsed patients in Cohort II.
Post-node dissection clearance rate of ctDNA	At screening and every 4 months up to 2 years	The clearance rate of ctDNA in the node dissection patients in Cohort II.

Countries

United States

Contacts

CONTACTMarietta Moore, RN

marlmoor@iu.edu317-274-7477

PRINCIPAL_INVESTIGATORNabil Adra, MD

Indiana University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026