NCT07038733

Investigation of Lymph Node Biology in Kidney Cancer

Characterizing the Tumor-draining Lymph Nodes and Other Immune Sites in Renal Cell Carcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. We 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.

Conditions

• Renal Cell Carcinoma (RCC)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-30
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-06-26
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States