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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05112627
Other study ID # ROR2051
Secondary ID NCI-2021-1079420
Status Recruiting
Phase
First received
Last updated
Start date November 8, 2021
Est. completion date October 2025

Study information

Verified date December 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Undergo blood collection

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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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