Immunophenotyping in Metastatic Kidney Cancer Patients Receiving Ablative Therapy

NCT05112627 | Completed

• 3 other identifiers: ROR2051NCI-2021-1079420-011522
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Renal Cell Carcinoma; Stage IV Renal Cell Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in immune markers and PBMC characteristics in patients undergoing stereotactic body radiation therapy (SBRT) versus percutaneous cryoablation (PCA) and receiving concurrent immunotherapy

  Baseline up to 6 months

• Change in immune markers and PBMC characteristics in patients undergoing SBRT or PCA and not receiving concurrent immunotherapy

  Baseline up to 6 months

• Levels of post-treatment immune markers and PBMC characteristics

  Up to 6 months

Study Arms (1)

Observational (biospecimen collection)

Patients undergo blood sample collection at baseline prior to SBRT or PCA, then at 14 days, 3 and 6 months after SBRT or PCA.

Procedure: Biospecimen Collection

Interventions

Biospecimen Collection PROCEDURE

Undergo blood collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histological or radiographic diagnosis of metastatic RCC

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Bradley J. Stish, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 9, 2021
• Study Start: January 24, 2022
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

US (1)