Integrative Molecular Characterization Of MiT Family Translocation Renal Cell Carcinomas (IMCOR)

Renal Carcinoma Clinical Trial

— IMCOR  

Official title:

Integrative Molecular Characterization Of MiT Family Translocation Renal Cell Carcinomas (IMCOR)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05456074
• Other study ID #: 4-2021-001
• Status: Not yet recruiting
• Start date: January 25, 2023
• Est. completion date: January 25, 2026

Study information

• Verified date: November 2022
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Valérie SARTORI
• Phone: 368767223
• Email: v.sartori[@]icans.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Microphthalmia transcription factor (MiT) family translocation renal cell carcinomas (TRCC) are rare subtypes of kidney cancers, which often arise in children and young adults. TRCC are characterized by translocations affecting transcription factors: Transcription Factor Binding To Immunoglobulin Heavy Constant Mu Enhancer 3 (TFE3) and Transcription Factor EB (TFEB). Little is known about TRCC molecular heterogeneity, in particular their transcriptomic and epigenetic subtype classification. Clinical behavior of TRCC is varying with age and Tumor, Node, Metastasis (TNM) stage. However, the biological basis of this aggressiveness is poorly understood.

PURPOSE: The primary goal of this study is to decipher specific alterations in aggressive TRCC, defined as cases with metastatic dissemination at diagnosis. To tackle this problem, a retrospective cohort of TRCC cases in children and young adults will be created. We will then perform integrative comprehensive multi-omics analysis of these tumors to identify genetic, epigenetic and immune biomarkers associated with metastatic behavior in a training and validation datasets. Comparison of the multi-omics data will be compared to other type of rare Kidney tumors as well as clear-cell renal cell carcinomas

Description:

This retrospective cohort study aims to allow tumor collection of TRCC from three different networks: the French research network in renal cancer (UroCCR), the International Society of Paediatric Oncology (SIOP) database and the network for rare renal carcinomas (CARARE). Those samples will be divided in training and validation datasets. We will also collect samples from patients with other rare kidney cancers and clear-cell renal cell carcinomas allowing comparisons of similarity and differences between these tumors.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: January 25, 2026
• Est. primary completion date: January 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients treated for kidney cancer in a clinical center located in France

For molecular biology study :

• Patients with tumor sample available for genetic and epigenetic analysis. Tumor sample stored in Biological resource facilities and consent given from patient or from parents for the use of biological sample for biomedical research purposes.

Exclusion Criteria:

• Objection from patient or parents

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Carcinoma

Intervention

Other:
• Data collection
Retrospective data collection

Locations

Country	Name	City	State
France	Réseau Français de Recherche sur le Cancer du Rein (UroCCR)	Bordeaux
France	Réseau SIOP, Hôpital Trousseau	Paris
France	Réseau CARARE	Rennes
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (3)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe	Ministry of Health, France, National Cancer Institute, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Herrscher H, Boilève A, Lindner V, Barthélémy P, Hutt É, Pierard L, Kurtz JE, Rioux-Leclercq N, Lang H, Malouf GG. [MiT family translocation renal cell carcinomas: Natural history, molecular features and multidisciplinary management]. Bull Cancer. 2020 Feb;107(2):272-280. doi: 10.1016/j.bulcan.2019.11.010. Epub 2020 Feb 7. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of genetic alterations associated with TRCC aggressiveness.	Tumor aggressiveness is defined as TRCC cases with metastatic dissemination at diagnosis. Comparison of recurrent genetic aberration identified between metastatic and localized cases.	at the end of the study (36 months)
Secondary	Progression free survival (PFS)	Testing for association between molecular tumor features and clinico-pathological patients outcome, PFS, according to the identity of TFE fusion partner	From renal tumor diagnosis to progression or latest patient news at the end of the study (36 months)
Secondary	Overall survival (OS)	Testing for association between molecular tumor features and clinico-pathological patients outcome, OS, according to the identity of TFE fusion partner	From renal tumor diagnosis to death or latest patient news at the end of the study (36 months)6 months)
Secondary	Contribution of DNA methylation, transcriptome and immune landscape to metastatic potential	Proportion of patients with metastatic disease in each DNA methylation and messenger RNA (mRNA) cluster using hierarchical unsupervised subtype classifications	at the end of the study (36 months)