Clinical and Therapeutic Impact of Large Genomic Studies... | NCT06171971

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

NCT06171971

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Dec 15, 2023Actual

Enrollment

230Estimated

Phase

Not provided

Conditions

Pediatric Solid Tumors

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2022Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Sep 6, 2022

First Submission Date that Met QC Criteria

Dec 12, 2023

First Posted Date

Dec 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2023

Last Update Posted Date

Dec 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

230Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

22 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Natacha ENTZ-WERLE, MD, PhD	Contact	33 3.88.12.87.94		natacha.entz-werle@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'onco-hématologie pédiatrique - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France