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

NCT05456074 | Unknown

• 1 other identifier: 4-2021-001
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Renal Carcinoma

Keywords

MiT family translocation renal cell carcinomas; Multiomics; Genetic; Epigenetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression free survival (PFS)

  From renal tumor diagnosis to progression or latest patient news at the end of the study (36 months)

• Overall survival (OS)

  From renal tumor diagnosis to death or latest patient news at the end of the study (36 months)6 months)

• Contribution of DNA methylation, transcriptome and immune landscape to metastatic potential

  at the end of the study (36 months)

Study Arms (2)

Patients with TRCC

Other: Data collection

Patients with other rare kidney tumors

Other: Data collection

Interventions

Data collection OTHER

Retrospective data collection

Patients with TRCC; Patients with other rare kidney tumors

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with TRCC and other rare kidney tumors

You may qualify if:

• 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.

You may not qualify if:

• Objection from patient or parents

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead
• National Cancer Institute, France: collaborator
• Ministry of Health, France: collaborator

Study Sites (4)

Réseau Français de Recherche sur le Cancer du Rein (UroCCR)

Bordeaux, France

Location

Réseau SIOP, Hôpital Trousseau

Paris, France

Location

Réseau CARARE

Rennes, France

Location

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location

Related Publications (1)

• Herrscher H, Boileve A, Lindner V, Barthelemy P, Hutt E, 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. French.

  PMID: 32044098 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples (DNA and RNA extraction)

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Gabriel MALOUF, MD, PhD

  Institut de cancérologie Strasbourg Europe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie SARTORI

CONTACT

368767223; v.sartori@icans.eu

Manon VOEGELIN

CONTACT

368339523; m.voegelin@icans.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: January 25, 2023
• Primary Completion: January 25, 2026
• Study Completion: January 25, 2026
• Last Updated: November 25, 2022

Record last verified: 2022-11

Locations

FR (4)