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
This trial does not accept healthy volunteersQualifiers
≥ 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
Design model
Parallel
Treatments tested in this trial
Whole blood for ctDNA
Diagnostic testWhole blood for ctDNA
Treatment groups
130 Participants
are divided into 3 treatment groupsGroup A: Cohort I - High Risk Clinical stage IExperimental treatment 1 intervention
Group B: Cohort II- Clinical stage IIExperimental treatment 1 intervention
Group C: Cohort III- Clinical stage IIIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At screening and every 4 months up to 2 years2
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.
Time frame
At screening and every 4 months up to 2 years3
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.
Time frame
At screening and every 4 months up to 2 yearsSecondary outcomes
1
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.
Time frame
At screening and every 4 months up to 2 years2
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.
Time frame
At screening and every 4 months up to 2 years3
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.
Time frame
At screening and every 4 months up to 2 years4
Post-node dissection circulating tumor DNA bioassay
Means/stds of ctDNA in both the relapsed and non-relapsed patients in Cohort II.
Time frame
At screening and every 4 months up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
Natera, Inc.
Collaborator
Source ClinicalTrials.gov