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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This study will assess whether DNA released by kidney cancer into the blood stream and urine of patients can be used to monitor tumor burden and tumor response to treatment in patients receiving immunotherapy
Primary Objective:
- Evaluate tumor cell free (cf)DNA as a dynamic marker of response to immuno-oncology (IO) therapy
Exploratory Objective:
- Collect data on somatic mutations in cfDNA to gain insight into the biology of IO-responders and -non-responders
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RCC with clear cell component |
| ||
| Healthy Volunteer (no longer recruiting) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection | Other | 20-40 mL of blood to extract cell free DNA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate tumor cfDNA as a dynamic marker of response to IO therapy | Measure of changes in the amount of tumor DNA correlated with result of routine tumor imaging studies | Up to about 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adults (18 year or older) with Renal Cell Carcinoma with clear cell component and receiving an IO-containing regimen or healthy volunteers (18 years or older)
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| Name | Affiliation | Role |
|---|---|---|
| Scott Haake, MD | Vanderbilt Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Valley Health Care System | Nashville | Tennessee | 37212 | United States | ||
| Vanderbilt University Medical Center |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2021 | May 6, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D059349 | Urine Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Urine collection | Other | up to 15 mL of urine to extract cell free DNA |
|
| Nashville |
| Tennessee |
| 37232 |
| United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |