Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
NCT Number: NCT07401316
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
Whole blood for ctDNA
Time frame: At screening and every 4 months up to 2 years
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
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
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
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
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
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 years
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
The clearance rate of ctDNA in the node dissection patients in Cohort II.
Contact information is provided by the study sponsor or research team.
Indiana University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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