NCT07038733 · Yale University
Investigation of Lymph Node Biology in Kidney Cancer
(LN-RCC)
What this study is about
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).
View original scientific description
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.
Interventions
PROCEDURE
Peripheral Blood Sample for Immune Analysis
A peripheral blood sample will be collected at the time of surgery.
PROCEDURE
Tumor Sample for Analysis
Extra tumor which is left over following clinical diagnoses will be collected.
PROCEDURE
Adjacent non-malignant kidney for analysis
Extra normal tissue which is left over following clinical diagnoses will be collected.
PROCEDURE
Draining lymph node(s) for analysis
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.
PROCEDURE
Regional non-draining lymph node(s) for analysis
Regional lymph nodes which have been deemed as non-draining by the surgeon will be collected.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- New Haven, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations