Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT07038733
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Lymph Node Biology in Kidney Cancer
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Characterizing the Tumor-draining Lymph Nodes and Other Immune Sites in Renal Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LN-RCC
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: