Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
Immunophenotyping in Metastatic Renal Cell Carcinoma Patients Receiving Ablative Therapy
Verified date | December 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | October 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histological diagnosis of primary RCC - Histological or radiographic diagnosis of metastatic RCC - Age >= 18 years - Eastern Cooperative Oncology Group (ECOG) performance status 0-3 - Feasible vascular access as determined by study staff - Undergoing standard of care SBRT or PCA to RCC metastatic lesion(s) - Provide written informed consent - Willing to consent to research blood draws - Willing to return to enrolling institution for follow-up Exclusion Criteria: - Prior local treatment of the index metastatic lesion - Pregnant or nursing women - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry - Patients receiving prophylactic steroids, defined as initiation of steroids within 1 week prior to local ablative therapy start, including the first day of local ablative therapy. - NOTE: Patients initiating steroids after the first day of local ablative therapy and within 14 days after local ablative therapy completion, will be allowed into the study and the use of steroids will be recorded. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in immune markers and peripheral blood mononuclear cell (PBMC) characteristics | Immune markers and PBMC characteristics will be evaluated overall. For change from baseline, comparisons between groups will be done using Analysis of Covariance (ANCOVA), including the pre-treatment count as a covariate in the model along with group status. The change will be described between groups reporting the mean and inter-quartile range. Linear regression will be used, analysis of covariance for change, for multiple variable models that will include any relevant baseline disease and patient characteristics. | Baseline up to 6 months | |
Secondary | Change in immune markers and PBMC characteristics in patients undergoing stereotactic body radiation therapy (SBRT) versus percutaneous cryoablation (PCA) and receiving concurrent immunotherapy | Each CD8+ T cell will be compared between the SBRT and PCA groups using a two-sample T test at each of the time points as well as for percent change from baseline. For change from baseline, comparisons between groups will be done using ANCOVA, including the pre-treatment count as a covariate in the model along with group status. The change will be described between groups reporting the mean and inter-quartile range. Linear regression will be used, analysis of covariance for change, for multiple variable models that will include any relevant baseline disease and patient characteristics. | Baseline up to 6 months | |
Secondary | Change in immune markers and PBMC characteristics in patients undergoing SBRT or PCA and not receiving concurrent immunotherapy | Each CD8+ T cell will be compared between the SBRT and PCA groups using a two-sample T test at each of the time points as well as for percent change from baseline. For change from baseline, comparisons between groups will be done using ANCOVA, including the pre-treatment count as a covariate in the model along with group status. The change will be described between groups reporting the mean and inter-quartile range. Linear regression will be used, analysis of covariance for change, for multiple variable models that will include any relevant baseline disease and patient characteristics. | Baseline up to 6 months | |
Secondary | Levels of post-treatment immune markers and PBMC characteristics | Will be correlated with distant disease progression overall (45 patients). Descriptive statistics will be used to summarize levels of immune markers and PBMC characteristics in the event of disease progression. | Up to 6 months |
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