MedPath

Investigation of Lymph Node Biology in Kidney Cancer

Not yet recruiting
Conditions
Renal Cell Carcinoma (RCC)
Registration Number
NCT07038733
Lead Sponsor
Yale University
Brief Summary

The purpose of this study is to create a Yale Renal Cell Carcinoma (RCC) Oncology data and biospecimen repository that will be used for current and future research projects involving the study of GU cancer biology and related medical conditions with a primary objective of investigating the TCR repertoire, phenotype, and effector functions of T cells within the tumor-draining lymph node.

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 existing tissue specimens and tissue specimens collected prospectively at relevant treatment time points (pre-treatment, response, primary or acquired resistance, and/or at the occurrence of toxicity) during the course of their participation in the study. 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, for all patients enrolled from the YCC Genitourinary Oncology Clinic, 20 mL of blood may be collected at enrollment and at relevant treatment time points (e.g., pre-treatment, response, primary or acquired resistance, and/or at the occurrence of toxicity) for correlative biomarker studies and the extraction of germline DNA.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
10
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.
  • Participants must not donate gametes (i.e., eggs or sperm) or freeze gametes for future use related to assisted reproduction.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mechanistic Insights into Resistance to Anti-Cancer Therapies in Kidney Cancer24 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.

Biomarkers for Predicting Toxicities of Anti-Cancer Therapies in Kidney Cancer Patients24 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.

Molecular Profiling of Tumor and Draining Lymph Node Tissues in Kidney Cancer Patients24 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

Molecular Responses to Anti-Cancer Therapies in Kidney Cancer Patients24 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Yale University

🇺🇸

New Haven, Connecticut, United States

Yale University
🇺🇸New Haven, Connecticut, United States
Jialing Zhang
Contact
jialing.zhang@yale.edu
David Braun
Principal Investigator

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