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

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.

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.

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