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NCT Number: NCT07401316

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Marietta Moore, RN

CONTACT

[email protected]

317-274-7477

Nabil Adra, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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

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

Treatment and study plan

Whole blood for ctDNA

Diagnostic Test

Whole blood for ctDNA

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Post-node dissection circulating tumor DNA bioassay

    Time frame: 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.

  5. Post-node dissection clearance rate of ctDNA

    Time frame: At screening and every 4 months up to 2 years

    The clearance rate of ctDNA in the node dissection patients in Cohort II.

Study contacts

Contact information is provided by the study sponsor or research team.

Marietta Moore, RN

CONTACT

[email protected]

317-274-7477

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Natera, Inc.

Registry information

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Feb 10, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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