Metastatic Renal Cell CarcinomaNCT05112627
Immunophenotyping in Metastatic Kidney Cancer Patients Receiving Ablative Therapy
An observational study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
- What is being tested?
- Biospecimen Collection
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histological or radiographic diagnosis of metastatic RCC
Who may be able to join
- 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)
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- Provide written informed consent
- Willing to consent to research blood draws
- Willing to return to enrolling institution for follow-up
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Immunophenotyping in Metastatic Renal Cell Carcinoma Patients Receiving Ablative Therapy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Biospecimen Collection
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood collection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline up to 6 months
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.
Measured: Baseline up to 6 months
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start24 Jan 2022
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley (Brad) Stish, Mayo Clinic
- Investigators
- Bradley J. Stish, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112627
- Sponsor's protocol ID
- ROR2051
- Other IDs
- NCI-2021-10794, 20-011522
- Status last verified
- Aug 2024
- First submitted
- 22 Oct 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunophenotyping in Metastatic Renal Cell Carcinoma Patients Receiving Ablative Therapy
- ClinicalTrials.gov ID
- NCT05112627
- Acronym / sponsor ID
- ROR2051
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (biospecimen collection) | – | Procedure: Biospecimen CollectionPatients undergo blood sample collection at baseline prior to SBRT or PCA, then at 14 days, 3 and 6 months after SBRT or PCA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histological or radiographic diagnosis of metastatic RCC
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood collection | Procedure or surgery | Observational (biospecimen collection) |
Primary outcome
Change in immune markers and peripheral blood mononuclear cell (PBMC) characteristics
Time frame: Baseline up to 6 months
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.
3 secondary outcomes
Change in immune markers and PBMC characteristics in patients undergoing stereotactic body radiation therapy (SBRT) versus percutaneous cryoablation (PCA) and receiving concurrent immunotherapy
Time frame: Baseline up to 6 months
Change in immune markers and PBMC characteristics in patients undergoing SBRT or PCA and not receiving concurrent immunotherapy
Time frame: Baseline up to 6 months
Levels of post-treatment immune markers and PBMC characteristics
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley J. Stish, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in immune markers and peripheral blood mononuclear cell (PBMC) characteristics (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.