Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT05112627
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2021-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunophenotyping in Metastatic Kidney Cancer Patients Receiving Ablative Therapy
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Immunophenotyping in Metastatic Renal Cell Carcinoma Patients Receiving Ablative Therapy
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This early phase I trial evaluates blood samples to see if patients undergoing standard of care treatment with either stereotactic body radiation therapy or percutaneous ablation (using radio waves to create heat to destroy the tumor), have an increase in serum immune markers in kidney cancer. Information gained from this study may help doctors make treatment decisions for patients with kidney cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I. Compare pre- and post-treatment immune markers and peripheral blood mononuclear cell (PBMC) characteristics in metastatic renal cell carcinoma (RCC) patients overall.
II. Compare pre- and post-treatment immune markers and PBMC characteristics between patients being treated with stereotactic body radiation therapy (SBRT) versus percutaneous cryoablation (PCA) and are also undergoing immunotherapy.
III. Compare pre- and post-treatment immune markers and PBMC characteristics in patients being treated with either SBRT or PCA and not undergoing immunotherapy.
IV. Assess the impact of post-treatment immune markers and PBMC characteristics on distant disease progression in metastatic RCC patients overall.
OUTLINE:
Patients undergo blood sample collection at baseline prior to SBRT or PCA, then at 14 days, 3 and 6 months after SBRT or PCA.
I. Compare pre- and post-treatment immune markers and peripheral blood mononuclear cell (PBMC) characteristics in metastatic renal cell carcinoma (RCC) patients overall.
II. Compare pre- and post-treatment immune markers and PBMC characteristics between patients being treated with stereotactic body radiation therapy (SBRT) versus percutaneous cryoablation (PCA) and are also undergoing immunotherapy.
III. Compare pre- and post-treatment immune markers and PBMC characteristics in patients being treated with either SBRT or PCA and not undergoing immunotherapy.
IV. Assess the impact of post-treatment immune markers and PBMC characteristics on distant disease progression in metastatic RCC patients overall.
OUTLINE:
Patients undergo blood sample collection at baseline prior to SBRT or PCA, then at 14 days, 3 and 6 months after SBRT or PCA.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: