Circulating Tumor DNA in Stage I, II, and III Germ-Cell Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole blood for ctDNA.
- Who it may be relevant to
- Registry conditions: Germ Cell Cancer Metastatic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test Whole blood for ctDNA
Whole blood for ctDNA
Primary outcome measures
- Positive predictive value (PPV) of circulating tumor DNA in Cohort I [Time frame: At screening and every 4 months up to 2 years]
- Positive predictive value (PPV) of circulating tumor DNA in Cohort II [Time frame: At screening and every 4 months up to 2 years]
- Positive predictive value (PPV) of circulating tumor DNA in Cohort III [Time frame: At screening and every 4 months up to 2 years]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis
Identifiers
NCT: NCT07401316 · CTO-IUSCCC-0937