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

November 23, 2022 updated by: Institut de cancérologie Strasbourg Europe

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France
        • Réseau Français de Recherche sur le Cancer du Rein (UroCCR)
        • Contact:
          • Jean-Christophe Bernhard, MD, PhD
      • Paris, France
        • Réseau SIOP, Hôpital Trousseau
        • Contact:
          • Aurore Coulomb, MD, PhD
      • Rennes, France
        • Réseau CARARE
        • Contact:
          • Nathalie Rioux-Leclercq, MD, PhD
      • Strasbourg, France, 67033
        • Institut de cancérologie Strasbourg Europe
        • Contact:
          • Gabriel MALOUF, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with TRCC and other rare kidney tumors

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with TRCC
Other: Data collection
Retrospective data collection
Patients with other rare kidney tumors
Other: Data collection
Retrospective data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of genetic alterations associated with TRCC aggressiveness.
Time Frame: at the end of the study (36 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: From renal tumor diagnosis to progression or latest patient news at the end of the study (36 months)
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)
Overall survival (OS)
Time Frame: From renal tumor diagnosis to death or latest patient news at the end of the study (36 months)6 months)
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)
Contribution of DNA methylation, transcriptome and immune landscape to metastatic potential
Time Frame: at the end of the study (36 months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de cancérologie Strasbourg Europe

Collaborators

Ministry of Health, France
National Cancer Institute, France

Investigators

  • Principal Investigator: Gabriel MALOUF, MD, PhD, Institut de cancérologie Strasbourg Europe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 25, 2023

Primary Completion (Anticipated)

January 25, 2026

Study Completion (Anticipated)

January 25, 2026

Study Registration Dates

First Submitted

July 8, 2022

First Submitted That Met QC Criteria

July 8, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Actual)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 23, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2021-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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