Renal Cell Carcinoma (RCC)LN-RCCNCT07038733
Investigation of Lymph Node Biology in Kidney Cancer
A study testing Peripheral Blood Sample for Immune Analysis, Tumor Sample for Analysis and Adjacent non-malignant kidney for analysis in people with Renal Cell Carcinoma (RCC), run by Yale University at 1 site in United States.
Trial summary
The purpose of this pilot study is to investigate the phenotype, anti-tumor effector functions, and TCR repertoire of T cells isolated from patient tumor draining lymph nodes (TDLNs) to understand T cell priming and trafficking patterns in Renal Cell Carcinoma (RCC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Cell Carcinoma (RCC)
- What is being tested?
- Peripheral Blood Sample for Immune Analysis, Tumor Sample for Analysis and Adjacent non-malignant kidney for analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Candidates for inclusion include adult patients with either a known or suspected kidney cancer referred to Yale Genitourinary Oncology providers in the Yale Urology, Medical Oncology and Radiation Oncology or Nephrology Departments. These individuals will be receiving clinical evaluation/medical treatment/surgery/procedures at Yale New Haven Hospital or the Smilow Cancer Hospital.
- Participant eligibility will be determined by study investigators and will be offered protocol details. Interested participants will be invited to participate by study investigators. Consent will be obtained by study investigators or other authorized study personnel. Any potential adult participants with known or suspected kidney cancers with a renal mass who are patients of non-study physicians will be invited to participate by study personal only with the approval of their treating physician.
Who cannot join
- Participants under the age of 18. Children will not be enrolled on the study.
- Participants known to be pregnant or actively breastfeeding.
- Iodine allergy hypersensitivity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06510
Jialing Zhang, jialing.zhang@yale.edu
David Braun
About this study
Official title: Characterizing the Tumor-draining Lymph Nodes and Other Immune Sites in Renal Cell Carcinoma
The purpose of this pilot study is to investigate the phenotype, anti-tumor effector functions, and TCR repertoire of T cells isolated from patient tumor draining lymph nodes (TDLNs) to understand T cell priming and trafficking patterns in Renal Cell Carcinoma (RCC). Data and biospecimen collected will be used for current and future research projects involving the study of kidney cancer biology and related medical conditions. Investigators will use this valuable resource to ask clinically relevant translational questions that pertain to biomarker discovery/validation, identification of novel therapeutic targets, and to better understand the genetic and biological basis of the various kidney cancers.
Read the detailed description
This is a protocol to collect and analyze tissue specimens from patients with kidney cancers. Patients with confirmed or suspected renal cell carcinoma (RCC) evaluated at the YCC Genitourinary Oncology Clinic or participating Smilow Cancer Hospital Care Centers (SCHCC) will be invited to participate in the study.
Participants will consent to the acquisition and analysis of prospective tissue specimens collected at relevant treatment time points (e.g., pre-treatment, response, primary or acquired resistance, and/or at the occurrence of toxicity), based on their cancer treatment course, whether routine care or as part of another clinical trial. Prospective tissue collection include fresh tissue collection at the time of procedures that are conducted at YNHH as part of standard of care (SOC) or clinical trial protocols (procedures billed to either insurance or trial sponsor). Tissue in excess of what is required for diagnostic/clinical uses will be used for research. If an adult participant consents, draining and regional lymph nodes may be obtained for research purposes.
In addition, 20 mL of blood may be collected at time of surgery for correlative biomarker studies and the extraction of germline DNA.
Eligible patients will be identified and consented by their treating clinician (PI or sub- investigators) and/or designated research staff.
- Conditions
- Renal Cell Carcinoma (RCC)
- Being tested
- Peripheral Blood Sample for Immune Analysis, Tumor Sample for Analysis, Adjacent non-malignant kidney for analysis, Draining lymph node(s) for analysis, Regional non-draining lymph node(s) for analysis
- 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.
Peripheral Blood Sample for Immune AnalysisProcedure or surgery
A peripheral blood sample will be collected at the time of surgery.
Tumor Sample for AnalysisProcedure or surgery
Extra tumor which is left over following clinical diagnoses will be collected.
Adjacent non-malignant kidney for analysisProcedure or surgery
Extra normal tissue which is left over following clinical diagnoses will be collected.
Draining lymph node(s) for analysisProcedure or surgery
Draining lymph nodes which have been identified by the surgeon visually, potentially using a tracer (injection of up to 5mg of ICG into the peritumor kidney) will be collected.
Regional non-draining lymph node(s) for analysisProcedure or surgery
Regional lymph nodes which have been deemed as non-draining by the surgeon will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Specimen collection | Experimental | This single arm study will assess adult patients with either a known or suspected kidney cancer referred to Yale Genitourinary Oncology providers in the Yale Urology, Medical Oncology, Radiation Oncology, or Nephrology Departments. Specimens collected will include peripheral blood sample for immune analysis, tumor sample for analysis, adjacent non-malignant kidney for analysis, draining lymph nodes for analysis and finally, regional non-draining lymph nodes for analysis. Receives: Procedure: Peripheral Blood Sample for Immune Analysis; Procedure: Tumor Sample for Analysis; Procedure: Adjacent non-malignant kidney for analysis; Procedure: Draining lymph node(s) for analysis; Procedure: Regional non-draining lymph node(s) for analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular Profiling of Tumor and Draining Lymph Node Tissues in Kidney Cancer Patients
This outcome measure focuses on the detailed molecular characterization of tumor and draining lymph node tissues collected from kidney cancer patients. The analysis will include genomic, transcriptomic, and proteomic profiling to understand the underlying biology of kidney cancers
Measured: 24 months
Molecular Responses to Anti-Cancer Therapies in Kidney Cancer Patients
This outcome measure aims to assess the molecular responses of kidney cancer tissues to anti-cancer therapies. It involves analyzing changes in the molecular profiles of tumor and lymph node tissues before and after treatment to evaluate therapeutic efficacy and identify potential biomarkers of response.
Measured: 24 months
Mechanistic Insights into Resistance to Anti-Cancer Therapies in Kidney Cancer
This outcome measure investigates the mechanisms of resistance to anti-cancer therapies in kidney cancer patients. The goal is to identify molecular alterations and signaling pathways associated with resistance, which could inform the development of strategies to overcome or prevent resistance.
Measured: 24 months
Biomarkers for Predicting Toxicities of Anti-Cancer Therapies in Kidney Cancer Patients
This outcome measure aims to identify biomarkers that can predict toxicities associated with anti-cancer therapies in kidney cancer patients. By analyzing molecular changes in tissues, the study seeks to develop predictive models to minimize adverse effects and personalize treatment regimens for better patient management.
These measures collectively aim to enhance our understanding of kidney cancer biology, responses to therapy, mechanisms of resistance, and toxicity prediction, thereby contributing to more effective and personalized treatment approaches.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start30 Jan 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Braun, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038733
- Sponsor's protocol ID
- 2000039529
- Acronym
- LN-RCC
- Status last verified
- Jun 2026
- First submitted
- 30 May 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Tumor-draining Lymph Nodes and Other Immune Sites in Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07038733
- Acronym / sponsor ID
- LN-RCC / 2000039529
- Conditions
- Renal Cell Carcinoma (RCC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Jun 2025 (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.
The purpose of this pilot study is to investigate the phenotype, anti-tumor effector functions, and TCR repertoire of T cells isolated from patient tumor draining lymph nodes (TDLNs) to understand T cell priming and trafficking patterns in Renal Cell Carcinoma (RCC). Data and biospecimen collected will be used for current and future research projects involving the study of kidney cancer biology and related medical conditions. Investigators will use this valuable resource to ask clinically relevant translational questions that pertain to biomarker discovery/validation, identification of novel therapeutic targets, and to better understand the genetic and biological basis of the various kidney cancers.
Detailed description
This is a protocol to collect and analyze tissue specimens from patients with kidney cancers. Patients with confirmed or suspected renal cell carcinoma (RCC) evaluated at the YCC Genitourinary Oncology Clinic or participating Smilow Cancer Hospital Care Centers (SCHCC) will be invited to participate in the study.
Participants will consent to the acquisition and analysis of prospective tissue specimens collected at relevant treatment time points (e.g., pre-treatment, response, primary or acquired resistance, and/or at the occurrence of toxicity), based on their cancer treatment course, whether routine care or as part of another clinical trial. Prospective tissue collection include fresh tissue collection at the time of procedures that are conducted at YNHH as part of standard of care (SOC) or clinical trial protocols (procedures billed to either insurance or trial sponsor). Tissue in excess of what is required for diagnostic/clinical uses will be used for research. If an adult participant consents, draining and regional lymph nodes may be obtained for research purposes.
In addition, 20 mL of blood may be collected at time of surgery for correlative biomarker studies and the extraction of germline DNA.
Eligible patients will be identified and consented by their treating clinician (PI or sub- investigators) and/or designated research staff.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specimen collection | Experimental | Procedure: Peripheral Blood Sample for Immune Analysis, Procedure: Tumor Sample for Analysis, Procedure: Adjacent non-malignant kidney for analysis, Procedure: Draining lymph node(s) for analysis, Procedure: Regional non-draining lymph node(s) for analysisThis single arm study will assess adult patients with either a known or suspected kidney cancer referred to Yale Genitourinary Oncology providers in the Yale Urology, Medical Oncology, Radiation Oncology, or Nephrology Departments. Specimens collected will include peripheral blood sample for immune analysis, tumor sample for analysis, adjacent non-malignant kidney for analysis, draining lymph nodes for analysis and finally, regional non-draining lymph nodes for analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Candidates for inclusion include adult patients with either a known or suspected kidney cancer referred to Yale Genitourinary Oncology providers in the Yale Urology, Medical Oncology and Radiation Oncology or Nephrology Departments. These individuals will be receiving clinical evaluation/medical treatment/surgery/procedures at Yale New Haven Hospital or the Smilow Cancer Hospital.
- Participant eligibility will be determined by study investigators and will be offered protocol details. Interested participants will be invited to participate by study investigators. Consent will be obtained by study investigators or other authorized study personnel. Any potential adult participants with known or suspected kidney cancers with a renal mass who are patients of non-study physicians will be invited to participate by study personal only with the approval of their treating physician.
Key exclusion criteria (3 listed)
- Participants under the age of 18. Children will not be enrolled on the study.
- Participants known to be pregnant or actively breastfeeding.
- Iodine allergy hypersensitivity.
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 |
|---|---|---|
| Peripheral Blood Sample for Immune AnalysisA peripheral blood sample will be collected at the time of surgery. | Procedure or surgery | Specimen collection |
| Tumor Sample for AnalysisExtra tumor which is left over following clinical diagnoses will be collected. | Procedure or surgery | Specimen collection |
| Adjacent non-malignant kidney for analysisExtra normal tissue which is left over following clinical diagnoses will be collected. | Procedure or surgery | Specimen collection |
| Draining lymph node(s) for analysisDraining lymph nodes which have been identified by the surgeon visually, potentially using a tracer (injection of up to 5mg of ICG into the peritumor kidney) will be collected. | Procedure or surgery | Specimen collection |
| Regional non-draining lymph node(s) for analysisRegional lymph nodes which have been deemed as non-draining by the surgeon will be collected. | Procedure or surgery | Specimen collection |
Primary outcome
Molecular Profiling of Tumor and Draining Lymph Node Tissues in Kidney Cancer Patients
Time frame: 24 months
This outcome measure focuses on the detailed molecular characterization of tumor and draining lymph node tissues collected from kidney cancer patients. The analysis will include genomic, transcriptomic, and proteomic profiling to understand the underlying biology of kidney cancers
Molecular Responses to Anti-Cancer Therapies in Kidney Cancer Patients
Time frame: 24 months
This outcome measure aims to assess the molecular responses of kidney cancer tissues to anti-cancer therapies. It involves analyzing changes in the molecular profiles of tumor and lymph node tissues before and after treatment to evaluate therapeutic efficacy and identify potential biomarkers of response.
Mechanistic Insights into Resistance to Anti-Cancer Therapies in Kidney Cancer
Time frame: 24 months
This outcome measure investigates the mechanisms of resistance to anti-cancer therapies in kidney cancer patients. The goal is to identify molecular alterations and signaling pathways associated with resistance, which could inform the development of strategies to overcome or prevent resistance.
Biomarkers for Predicting Toxicities of Anti-Cancer Therapies in Kidney Cancer Patients
Time frame: 24 months
This outcome measure aims to identify biomarkers that can predict toxicities associated with anti-cancer therapies in kidney cancer patients. By analyzing molecular changes in tissues, the study seeks to develop predictive models to minimize adverse effects and personalize treatment regimens for better patient management. These measures collectively aim to enhance our understanding of kidney cancer biology, responses to therapy, mechanisms of resistance, and toxicity prediction, thereby contributing to more effective and personalized treatment approaches.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
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Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
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Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.
Renal Cell Carcinoma
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.
David Braun, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Blood Sample for Immune Analysis, Tumor Sample for Analysis and Adjacent non-malignant kidney for analysis in people with Renal Cell Carcinoma (RCC), run by Yale University 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Ladd (954-895-0576, stephanie.ladd@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular Profiling of Tumor and Draining Lymph Node Tissues in Kidney Cancer Patients (time frame: 24 months). The study lists 4 primary outcomes in all. 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 16 Jun 2026.