Clinical trial · Observational
Immunophenotyping in Metastatic Kidney Cancer Patients Receiving Ablative Therapy
Immunophenotyping in Metastatic Renal Cell Carcinoma Patients Receiving Ablative Therapy
NCT05112627CI-TRIAL-00079651completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IV Renal Cell Cancer AJCC v8 | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (biospecimen collection)
- description
- Patients undergo blood sample collection at baseline prior to SBRT or PCA, then at 14 days, 3 and 6 months after SBRT or PCA.
- interventionNames
- Procedure: Biospecimen Collection
Primary outcomes (1)
- measure
- Change in immune markers and peripheral blood mononuclear cell (PBMC) characteristics
- timeFrame
- Baseline up to 6 months
- description
- 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.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.