Clinical and Therapeutic Impact of Large Genomic Studies at Diagnosis in Pediatric Solid Cancers (CS-PEDIA)

December 12, 2023 updated by: University Hospital, Strasbourg, France

Evaluation of the Clinical and Therapeutic Impact of Large Genomic Studies at Diagnosis in Pediatric Solid Cancers

Pediatric solid tumors with an unfavorable prognosis remain a public health issue due to their morbidity and mortality and their rapidly evolving profile. They are defined by an expected overall survival of < 30%. Progress has been made in genomic medicine with existing recommendations for the adult population, with the objective of personalized medicine. Recommendations for the pediatric population are still under consideration

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

230

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
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'onco-hématologie pédiatrique - CHU de Strasbourg - France
        • Principal Investigator:
          • Natacha ENTZ-WERLE, MD, PhD
        • Sub-Investigator:
          • Véronique LINDNER, MD
        • Sub-Investigator:
          • Benoit LHERMITTE, MD
        • Contact:
        • Sub-Investigator:
          • Juliette SIMON, MD
        • Sub-Investigator:
          • Eric GUERIN, MD
        • Sub-Investigator:
          • Sarah JANNIER, MD
        • Sub-Investigator:
          • Damien REITA, MD
        • Sub-Investigator:
          • Noelle WEINGERTNER, MD

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

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients of pediatric age up to 22 years included at the time of molecular analysis

Description

Inclusion criteria

  • Patients of pediatric age up to 22 years included at the time of molecular analysis
  • Histological carcinological diagnosis performed at HUS
  • Carcinological follow-up performed at HUS
  • Patients with a solid tumor of unfavorable prognosis, refractory or in relapse
  • Molecular analysis performed on tumor or blood samples
  • Adult patients who do not object to the re-use of their personal data for medical research purposes
  • Minor patients and their parents who do not object to the re-use of their personal data for scientific research purposes.

Criteria for non-inclusion

  • Molecular biology results not usable due to poor sample quality or insufficient genetic material
  • Patients who have expressed their opposition to participate in the study
  • Parental authority holders who have expressed their opposition to participate in the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrospective description of the clinical and therapeutic impact of the systematic performance of molecular analyzes on solid tumors
Time Frame: up to 12 months
The aim of this retrospective study is to improve and harmonize international practices
up to 12 months

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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 (Actual)

June 20, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Estimated)

December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8661

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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