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RecruitingNCT06171971CS-PEDIAUpdated Dec 15, 2023

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

An observational study in Pediatric Solid Tumors, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 1 Year to 22 Years. Per ClinicalTrials.gov, last updated 2023-12-15.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Jun 2022; still recruiting 4 years 3 months later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
230
Ages
1 Year to 22 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Pediatric Solid Tumors

Keywords

  • Pediatric solid tumors
  • BROAD GENOMIC STUDIES
  • SOLID CANCERS
  • Genomic medicine
03

In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 22 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
230 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Retrospective description of the clinical and therapeutic impact of the systematic performance of molecular analyzes on solid tumors

    The aim of this retrospective study is to improve and harmonize international practices

    Time frame: up to 12 months

07

Study locations

1 of 1 sites recruiting
  • Service d'onco-hématologie pédiatrique - CHU de Strasbourg - France
    Strasbourg, 67091, France
    • Natacha ENTZ-WERLE, MD, PhD · Contact · natacha.entz-werle@chru-strasbourg.fr · 33 3.88.12.87.94
    • Natacha ENTZ-WERLE, MD, PhD · Principal investigator
    • Juliette SIMON, MD · Sub investigator
    • Eric GUERIN, MD · Sub investigator
    • Sarah JANNIER, MD · Sub investigator
    • Damien REITA, MD · Sub investigator
    • Véronique LINDNER, MD · Sub investigator
    • Noelle WEINGERTNER, MD · Sub investigator
    • Benoit LHERMITTE, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06171971
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Dec 15, 2023
Start date
Jun 20, 2022
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Dec 15, 2023

Study contacts

Natacha ENTZ-WERLE, MD, PhD
Contact
natacha.entz-werle@chru-strasbourg.fr
33 3.88.12.87.94

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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