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NCT Number: NCT07038733

Investigation of Lymph Node Biology in Kidney Cancer

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.

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Key information

Conditions

Renal Cell Carcinoma (RCC) Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06510, United States

Location status: Recruiting

Location contact

David Braun

PRINCIPAL_INVESTIGATOR

Jialing Zhang

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peripheral Blood Sample for Immune Analysis

Procedure

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

Tumor Sample for Analysis

Procedure

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

Adjacent non-malignant kidney for analysis

Procedure

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

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.

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Ladd

CONTACT

[email protected]

954-895-0576

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Acronym: LN-RCC

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 26, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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