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NCT07038733NARecruitingAccepts Healthy Volunteers

Investigation of Lymph Node Biology in Kidney Cancer

Yale University

Start Date

1/30/2026

Completion Date

12/1/2030

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). 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

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

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Conditions

Renal Cell Carcinoma (RCC)

Locations

Yale University

New Haven, Connecticut 06510

United States