Investigation of Lymph Node Biology in Kidney Cancer

NCT07038733 | Recruiting DMC

• 1 other identifier: 2000039529
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma (RCC)

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

  24 months

Study Arms (1)

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.

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

Interventions

Peripheral Blood Sample for Immune Analysis PROCEDURE

A peripheral blood sample will be collected at the time of surgery.

Specimen collection

Tumor Sample for Analysis PROCEDURE

Extra tumor which is left over following clinical diagnoses will be collected.

Specimen collection

Adjacent non-malignant kidney for analysis PROCEDURE

Extra normal tissue which is left over following clinical diagnoses will be collected.

Specimen collection

Draining lymph node(s) for analysis PROCEDURE

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.

Specimen collection

Regional non-draining lymph node(s) for analysis PROCEDURE

Regional lymph nodes which have been deemed as non-draining by the surgeon will be collected.

Specimen collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• David Braun, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Ladd

CONTACT

954-895-0576; stephanie.ladd@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 26, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)