Immunophenotyping in Metastatic Kidney Cancer Patients Receiving Ablative Therapy
NCT ID: NCT05112627
Last Updated: 2024-08-09
Study Results
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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COMPLETED
15 participants
OBSERVATIONAL
2022-01-24
2024-05-15
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
Undergo blood collection
Interventions
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Biospecimen Collection
Undergo blood collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Bradley (Brad) Stish
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
Countries
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Related Links
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Mayo Clinic Clinical Trials
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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