Investigation of Lymph Node Biology in Kidney Cancer
ConditionRenal Cell Carcinoma (RCC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Peripheral Blood Sample for Immune Analysis
Procedure/SurgeryA peripheral blood sample will be collected at the time of surgery.
Tumor Sample for Analysis
Procedure/SurgeryExtra tumor which is left over following clinical diagnoses will be collected.
Adjacent non-malignant kidney for analysis
Procedure/SurgeryExtra normal tissue which is left over following clinical diagnoses will be collected.
Draining lymph node(s) for analysis
Procedure/SurgeryDraining 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/SurgeryRegional lymph nodes which have been deemed as non-draining by the surgeon will be collected.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Specimen collectionExperimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Molecular Profiling of Tumor and Draining Lymph Node Tissues in Kidney Cancer Patients
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
Time frame
24 months2
Molecular Responses to Anti-Cancer Therapies in Kidney Cancer Patients
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.
Time frame
24 months3
Mechanistic Insights into Resistance to Anti-Cancer Therapies in Kidney Cancer
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.
Time frame
24 months4
Biomarkers for Predicting Toxicities of Anti-Cancer Therapies in Kidney Cancer Patients
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.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov