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| Name | Class |
|---|---|
| Natera, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort I - High Risk Clinical stage I | Experimental | 50 subjects will be enrolled with high-risk stage I seminomatous or non-seminomatous germ cell tumors. In these patients, ctDNA will be collected post-orchiectomy prior to initiation of surveillance and every 4 months during surveillance for up to 2 years. |
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| Cohort II- Clinical stage II | Experimental | 30 patients will be enrolled with clinical Stage II seminomatous or non-seminomatous germ cell tumor who are planning to undergo primary resection with RPLND. In these patients, ctDNA will be collected prior to surgery and every 4 months after surgery for up to 2 years. |
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| Cohort III- Clinical stage III | Experimental | 50 patients will be enrolled with clinical Stage III (or IS) seminomatous or non-seminomatous germ cell tumor who are planning to undergo first-line chemotherapy. In these patients, ctDNA will be collected prior to chemotherapy, at cycle 2 day 1, within 28 days of starting last cycle of chemotherapy, and every 4 months after completing chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole blood for ctDNA | Diagnostic Test | Whole blood for ctDNA |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | At screening and every 4 months up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At screening and every 4 months up to 2 years |
| Negative predictive value (NPV) of circulating tumor DNA in Cohort II |
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Inclusion Criteria:
≥ 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.
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.
Archival tissue for germ-cell tumor diagnosis available
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marietta Moore, RN | Contact | 317-274-7477 | marlmoor@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nabil Adra, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
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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. |
| 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. | 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. | 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. | At screening and every 4 months up to 2 years |