Circulating Tumor DNA in Stage I, II, and III Germ-Cell Tumors
ConditionGerm Cell Cancer Metastatic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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.
Eligibility criteria
Qualifiers
≥ 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.
Archival tissue for germ-cell tumor diagnosis available
Disqualifiers
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 design
Treatments tested in this trial
- Whole blood for ctDNA
Treatment groups
130 Participants
are divided into 3 treatment groupsSponsors and collaborators
Indiana University
Lead sponsor
Natera, Inc.
Collaborator
Source ClinicalTrials.gov