Use of Specific Genetic Alteration s of Tumoral Cells Identified by the Next Generation Sequencing Techniques (NGS) to Follow Peripheral Samples of Children With Metastatic and/or High Risk Solid Tumor - NGSKids

Not Applicable

Completed

• Conditions: Metastatic and/or High Risk Solid Tumor of Children
• Interventions: Biological: Tumoral specific genetic alterations

• Registration Number: NCT02546453
• Lead Sponsor: Institut Curie

Brief Summary

The search for genetic alterations in primary tumor by NGS techniques followed by the detection of these alterations in circulating tumor DNA and/or CTC/DTC present in peripheral samples (blood, cerebrospinal fluid, bone marrow, possibly urine) collected during several steps and after the treatment could be a tool to monitor the response during and after the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-09-08
• Study First Posted: 2015-09-10
• Primary Completion: 2021-01
• Study Completion: 2021-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Children with metastatic and/or high risk solid tumor, of the following pathologies :

Neuroblastoma, sarcoma, malignant brain tumor (medulloblastoma, high-grade glioma), bone tumors, rhabdoid tumors, others rare tumors

• Availability of a frozen tumoral sample (primary tumor or metastasis whatever the localization) at diagnosis allowing analysis of genetic alterations by a NGS technique
• Age < 18 years
• Signed informed consent by parents or legal representatives
• Patient having health care insurance

Exclusion Criteria :

• Age ≥ 18 years
• No signed informed consent by parents or legal representatives

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumoral specific genetic alterations	Tumoral specific genetic alterations	NGS techniques (next generation sequencing) will be used to identify specific genetic alterations of tumoral cells of a patient. If specific genetic alterations is detected, they will be used to detect circulating tumor DNA and/or circulating/disseminated tumoral cells (CTC/DTC) in peripheral samples (blood, bone marrow, cerebral spinal fluid) collected before, during and after treatment.

Primary Outcome Measures

Name	Time	Method
Detection by Polymerase Chain Reaction (PCR) of specific genetic alterations	at the inclusion	Genetic alterations which have been previously detected by NGS technique in the tumor, in circulating tumoral DNA and/or CTC/DTC present in a blood sample at the inclusion.
Detection of specific genetic alterations of tumoral cells in peripheral samples	Up to 6 years	Detection of specific genetic alterations of tumoral cells in peripheral samples for which presence of tumoral cells has been confirmed by conventional clinic techniques (cytology, anatomopathology, immunohistochemistry

Secondary Outcome Measures

Name	Time	Method
Change of CTC/DTC/circulating tumoral DNA levels detected by PCR targeting specific genetic alterations of tumoral cells in peripheral samples will be confronted to clinical features including patient outcome	Up to 6 years
Detection of genetic alterations in solid tumor pediatric samples	At the inclusion	Use of identified genetic alterations in solid tumor pediatric samples to help to confirm diagnosis and prognosis and to search for new therapeutic targets

Trial Locations

Locations (1)

Institut Curie; 🇫🇷 Paris, France