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Finding New Targets by Proteomic Approaches (InnovRT1) (InnovRT1)

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ClinicalTrials.gov Identifier: NCT04868799
Recruitment Status : Not yet recruiting
First Posted : May 3, 2021
Last Update Posted : December 8, 2021
Sponsor:
Collaborators:
Institut Curie
Sainte Anne hospital
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
The investigators aim to explore the inter tumor heterogeneity by a proteomic approach of a wide series of rhabdoid tumors, from both intra and extra cranial origins.

Condition or disease Intervention/treatment
ATRT Biological: Mass spectrometry

Detailed Description:

Context: Rhaboid tumors (RT) are aggressive cancers of young infants, exposed to the toxicity of heavy treatments often ineffective, which justifies the need to identify new treatment strategies. These tumors are characterized by the biallelic alteration of SMARCB1 gene, encoding one of the subunits of the SWI/SNF complex, a chromatin remodeler. These mutations are the only ones found in these very stable cancers, which offers few therapeutic targets that can be identified by genomic techniques. They are morphologically undifferentiated and pluriphenotypic, suggesting the existence of a cellular diversity still poorly described. To advance on these questions, the investigators' laboratory has developed a model of genetically engineered mouse model spontaneously developing RT, biologically very similar to their human counterparts.

Objectives and methods: The investigators' project aims to describe the proteomic and phosphoproteomic signatures of these tumors, so far described at the genome and transcriptome level; an integration of these pangenomic / pan-proteomic studies will reveal the most relevant features to target. The investigators will fully characterize the proteomic and phosphoproteomic landscape using mass spectrometry on a cohort of clinically, radiologically and histopathologically annoted ATRT, for which methylome and RNAseq profiling will also be done. The investigators will describe the proteomic features of each molecularly defined subgroups, and aim to correlate RNAseq changes with proteomic features.

Patients will be included if they or their legal representative have given a consent to such a study, and if frozen material is stored at Necker Hospital.

Expected results: This analysis helps to identify how to articulate several innovative therapeutic approaches, taking into account both the diversity of the cells to be treated, and the real targets, proteins, to inhibit or restore.

Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Heterogeneity in Rhabdoid Tumors : Proteomic and Single-Cell Analyses to Identify New Therapeutic Targets
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
ATRT
Patients <18 years with an ATRT having frozen samples
 Biological: Mass spectrometry
Characterization of the proteomic and phosphoproteomic landscape using mass spectrometry


Outcome Measures
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Primary Outcome Measures :
  1. Identification of proteomic signature for each molecular subgroup of ATRT [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cohort of clinically, radiologically and histopathologically annoted ATRT
Criteria

Inclusion Criteria:

  • Aged 0-17 years old
  • Rhabdoid tumor, treated in oncology departments in Ile de France
  • frozen samples collected in usual care
  • parents' agreement for samples collection in usual care

Exclusion Criteria

  • Unconfirmed diagnosis of Rhabdoid tumor with molecular analyses Samples
  • paraffin embedded tissues
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04868799


Contacts
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Contact: Franck BOURDEAUT, MD 01 44 32 44 71 franck.bourdeaut@curie.fr
Contact: Nelly BRIAND, PhD 01 44 38 18 62 nelly.briand@aphp.fr

Locations
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France
Service de neurochirurgie - Hôpital Necker Enfants malades
Paris, France, 75015
Contact: Franck BOURDEAUT, MD    01 44 32 44 71    franck.bourdeaut@curie.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut Curie
Sainte Anne hospital
Investigators
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Study Director: Kevin Beccaria, MD, PhD APHP Assistance Publique des Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04868799    
Other Study ID Numbers: APHP201123
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
SMARCB1
ATRT
Brain Tumors
Proteomic
Multi-omics