Investigation of Lymph Node Biology in Kidney Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peripheral Blood Sample for Immune Analysis, Tumor Sample for Analysis, Adjacent non-malignant kidney for analysis, Draining lymph node(s) for analysis.
- Who it may be relevant to
- Registry conditions: Renal Cell Carcinoma (RCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterizing the Tumor-draining Lymph Nodes and Other Immune Sites in Renal Cell Carcinoma
Overview
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.
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.
Interventions
- Procedure Peripheral Blood Sample for Immune Analysis
A peripheral blood sample will be collected at the time of surgery. - Procedure Tumor Sample for Analysis
Extra tumor which is left over following clinical diagnoses will be collected. - Procedure Adjacent non-malignant kidney for analysis
Extra normal tissue which is left over following clinical diagnoses will be collected. - Procedure 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. - Procedure 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 measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Yale University — New Haven
Identifiers
NCT: NCT07038733 · 2000039529