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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
130
Whole blood for ctDNA
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
RECRUITINGPositive 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 years
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 years
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 years
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 years
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 years
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.
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Time frame: At screening and every 4 months up to 2 years
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 years
Post-node dissection clearance rate of ctDNA
The clearance rate of ctDNA in the node dissection patients in Cohort II.
Time frame: At screening and every 4 months up to 2 years