Immunophenotyping in Metastatic Kidney Cancer Patients Receiving Ablative Therapy

NCT ID: NCT05112627

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-24

Study Completion Date

2024-05-15

Brief Summary

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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

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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.

Conditions

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Metastatic Renal Cell Carcinoma Stage IV Renal Cell Cancer AJCC v8

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood collection

Interventions

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Biospecimen Collection

Undergo blood collection

Intervention Type PROCEDURE

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Bradley (Brad) Stish

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bradley J. Stish, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2021-10794

Identifier Type: REGISTRY

Identifier Source: secondary_id

20-011522

Identifier Type: OTHER

Identifier Source: secondary_id

ROR2051

Identifier Type: -

Identifier Source: org_study_id

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