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

Pediatric Solid Tumors Clinical Trial

— CS-PEDIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06171971
• Other study ID #: 8661
• Status: Recruiting
• Start date: June 20, 2022
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: Natacha ENTZ-WERLE, MD, PhD
• Phone: 33 3.88.12.87.94
• Email: natacha.entz-werle[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Gender: All
• Age group: 1 Year to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Solid Tumors

Locations

Country	Name	City	State
France	Service d'onco-hématologie pédiatrique - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 12 months