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.
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.
Eligibility
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
