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临床试验/NCT07351266
NCT07351266尚未招募不适用

Multi-omics Analysis of Renal Cell Carcinoma Mechanisms; Drug Sensitivity Testing in Patient-Derived Cell-based Microtumors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences0 个研究点目标入组 10 人开始时间: 2026年1月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
10

研究概览

简要总结

This is a research study aiming to better understand a type of kidney cancer called Renal Cell Carcinoma (RCC). Doctors have observed that inside some larger RCC tumors, there are multiple smaller nodules. This study wants to find out if these nodules are different from each other and how they might be related.

To do this, researchers will study tumor tissue samples from 10 patients with RCC who are having surgery. From each tumor, several nodules will be analyzed using advanced laboratory techniques. These techniques will create very detailed maps of the genes and cells within each nodule. At the same time, tiny 3D tumor models (called microtumors) will be grown from these samples in the lab to test how they respond to different cancer drugs.

The main goal is to combine these two types of information to see how the differences in genes and cells between nodules might explain why some tumors stop responding to treatment (become resistant). We hope this study will lead to a deeper understanding of how RCC grows and spreads, and help find new ways to diagnose and treat it in the future.

详细描述

Background and Rationale: Renal Cell Carcinoma (RCC) frequently exhibits intratumoral morphological heterogeneity, often presenting as distinct multiple nodules within a single tumor mass on cross-section. The biological and clinical significance of this multinodular architecture remains poorly understood. It is hypothesized that these nodules may represent clonal subpopulations with unique genomic, transcriptomic, and functional profiles, potentially driving tumor progression and therapy resistance. This study leverages integrated multi-omics and functional drug testing to systematically decipher the inter-nodular heterogeneity and evolutionary relationships within RCC.

Primary Objectives:

To delineate the cellular and genomic landscape of different intratumoral nodules in RCC using single-cell RNA sequencing (scRNA-seq), whole-exome sequencing (WES), and spatial transcriptomics.

To infer the potential clonal evolutionary relationships and driver-subordinate dynamics between coexisting nodules.

To characterize the differential drug sensitivity profiles of patient-derived microtumor (PTC) models established from distinct nodules.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically confirmed renal cell carcinoma with regional lymph node metastasis.
  • Primary tumor with a maximum diameter ≥ 7 cm.
  • Tumor exhibits a multinodular distribution pattern on cross-section (assessed via intraoperative or postoperative gross specimen).
  • Age > 18 years.
  • Ability to understand the study and voluntarily provide written informed consent.

排除标准

  • Presence of distant metastasis (M1 stage).
  • Prior receipt of any targeted therapy or immunotherapy for renal cell carcinoma before surgery.
  • History of other active malignancies besides RCC (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
  • Any psychiatric, neurological, or legal condition that may compromise the ability to understand the informed consent or to comply with study procedures.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiongjun Ye

Chief Physician

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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