Идёт набор NCT07038733

Investigation of Lymph Node Biology in Kidney Cancer

Без фазы С лечением Renal Cell Carcinoma (RCC)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Peripheral Blood Sample for Immune Analysis, Tumor Sample for Analysis, Adjacent non-malignant kidney for analysis, Draining lymph node(s) for analysis.
Кому может быть актуально: Состояния в реестре: Renal Cell Carcinoma (RCC). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Characterizing the Tumor-draining Lymph Nodes and Other Immune Sites in Renal Cell Carcinoma

Обзор

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.

Подробное описание

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.

Вмешательства

Процедура Peripheral Blood Sample for Immune Analysis
A peripheral blood sample will be collected at the time of surgery.
Процедура Tumor Sample for Analysis
Extra tumor which is left over following clinical diagnoses will be collected.
Процедура Adjacent non-malignant kidney for analysis
Extra normal tissue which is left over following clinical diagnoses will be collected.
Процедура 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.
Процедура Regional non-draining lymph node(s) for analysis
Regional lymph nodes which have been deemed as non-draining by the surgeon will be collected.

Первичные конечные точки

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

Критерии участия

Критерии включения

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.