Recruiting

Renal Cell Carcinoma

Sponsor:

Yale University

Code:

NCT07038733

Conditions

Renal Cell Carcinoma (RCC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Peripheral Blood Sample for Immune Analysis

Tumor Sample for Analysis

Adjacent non-malignant kidney for analysis

Draining lymph node(s) for analysis

Regional non-draining lymph node(s) for analysis

Study Details

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. 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.

Conditions

Renal Cell Carcinoma (RCC)

Study ID

NCT07038733

Start date

Jan 30, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

33 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Specimen collection

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.

Interventions

Peripheral Blood Sample for Immune Analysis

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

Tumor Sample for Analysis

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

Adjacent non-malignant kidney for analysis

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

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.

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 measure

  • Molecular Profiling of Tumor and Draining Lymph Node Tissues in Kidney Cancer Patients [ Time Frame: 24 months ]
  • Molecular Responses to Anti-Cancer Therapies in Kidney Cancer Patients [ Time Frame: 24 months ]
  • Mechanistic Insights into Resistance to Anti-Cancer Therapies in Kidney Cancer [ Time Frame: 24 months ]
  • Biomarkers for Predicting Toxicities of Anti-Cancer Therapies in Kidney Cancer Patients [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Stephanie Ladd

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

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Jialing Zhang

jialing.zhang@yale.edu

Principal Investigator:

David Braun

More Information

Sponsor

Yale University

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.