Germ Cell Cancer MetastaticNCT07401316
Circulating Tumor DNA in Stage I, II, and III Germ-Cell Tumors
A study testing Whole blood for ctDNA in people with Germ Cell Cancer Metastatic, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Germ Cell Cancer Metastatic
- What is being tested?
- Whole blood for ctDNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2026to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Marietta Moore, RN, 317-274-7477, kaelmoor@iu.edu
Nabil Adra, MD
About this study
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.
Read the 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.
- Conditions
- Germ Cell Cancer Metastatic
- Being tested
- Whole blood for ctDNA
- Keywords
- ctDNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole blood for ctDNADiagnostic test
Whole blood for ctDNA
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Whole blood for ctDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At screening and every 4 months up to 2 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At screening and every 4 months up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start3 Jun 2026
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Natera, Inc.
- Responsible party
- Principal investigator, Nabil Adra, Indiana University
- Investigators
- Nabil Adra, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401316
- Sponsor's protocol ID
- CTO-IUSCCC-0937
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA in Stage I, II, and III Germ-Cell Tumors
- ClinicalTrials.gov ID
- NCT07401316
- Acronym / sponsor ID
- CTO-IUSCCC-0937
- Conditions
- Germ Cell Cancer Metastatic
- Keywords
- ctDNA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Natera, Inc.
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort I - High Risk Clinical stage I | Experimental | Diagnostic Test: Whole blood for ctDNA50 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. |
| Cohort II- Clinical stage II | Experimental | Diagnostic Test: Whole blood for ctDNA30 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. |
| Cohort III- Clinical stage III | Experimental | Diagnostic Test: Whole blood for ctDNA50 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole blood for ctDNAWhole blood for ctDNA | Diagnostic test | Cohort I - High Risk Clinical stage I, Cohort II- Clinical stage II, Cohort III- Clinical stage III |
Primary outcome
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.
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.
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.
5 secondary outcomes
Negative predictive value (NPV) of circulating tumor DNA in Cohort I
Time frame: At screening and every 4 months up to 2 years
Negative predictive value (NPV) of circulating tumor DNA in Cohort II
Time frame: At screening and every 4 months up to 2 years
Negative predictive value (NPV) of circulating tumor DNA in Cohort III
Time frame: At screening and every 4 months up to 2 years
Post-node dissection circulating tumor DNA bioassay
Time frame: At screening and every 4 months up to 2 years
Post-node dissection clearance rate of ctDNA
Time frame: At screening and every 4 months up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nabil Adra, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole blood for ctDNA in people with Germ Cell Cancer Metastatic, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marietta Moore, RN (317-274-7477, marlmoor@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.