Clinical trial · Observational
Multi-omics Analysis of Renal Cell Carcinoma Mechanisms; Drug Sensitivity Testing in Patient-Derived Cell-based Microtumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma (Kidney Cancer) | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-region Tumor Sampling and Integrated Multi-omics Analysis and Microtumor PTC Drug Sensitivity Assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study Cohort
- description
- All enrolled participants undergo the same study procedures. This includes surgical resection of the renal cell carcinoma tumor, followed by multi-region sampling of intratumoral nodules for integrated multi-omics analysis (single-cell RNA sequencing, whole-exome sequencing, spatial transcriptomics) and the generation of patient-derived microtumor (PTC) models for ex vivo drug sensitivity testing.
- interventionNames
- Diagnostic Test: Multi-region Tumor Sampling and Integrated Multi-omics Analysis and Microtumor PTC Drug Sensitivity Assay
Primary outcomes (1)
- measure
- Identification of Intra-tumoral Nodule Driving Relationships
- timeFrame
- Through study completion, an average of 16 months
- description
- The primary outcome is the bioinformatic inference of potential clonal evolutionary "driver-subordinate" relationships between different intratumoral nodules within the same RCC tumor. This is determined by integrating multi-region single-cell RNA sequencing and whole-exome sequencing data. Key analyses include: 1) Comparative analysis of mutational landscapes and copy number variations across nodules to identify shared trunk mutations and private branch mutations. 2) Pseudotime trajectory analysis of single-cell data to reconstruct the potential temporal sequence of nodule emergence. A relationship will be inferred if a consistent pattern of shared ancestral mutations and/or a unidirectional differentiation trajectory is identified.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available