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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

Use of Specific Genetic Alteration s of Tumoral Cells Identified by NGS to Follow Peripheral Samples of Children With Metastatic and/or High Risk Solid Tumor -

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02546453
Acronym
NGSKids
Enrollment
30
Registered
2015-09-10
Start date
2014-09-30
Completion date
2021-01-31
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic and/or High Risk Solid Tumor of Children

Keywords

high risk solid tumor pediatric, genetic alteration, Metastatic solid tumor pediatric

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.

Interventions

BIOLOGICALTumoral specific genetic alterations

A buccal swab and a blood sample will be used at the diagnostic to identify the specific genetic alterations of tumoral cells.

Sponsors

Institut Curie
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Detection by Polymerase Chain Reaction (PCR) of specific genetic alterationsat the inclusionGenetic 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 samplesUp to 6 yearsDetection 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

MeasureTime frameDescription
Detection of genetic alterations in solid tumor pediatric samplesAt the inclusionUse of identified genetic alterations in solid tumor pediatric samples to help to confirm diagnosis and prognosis and to search for new therapeutic targets
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 outcomeUp to 6 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026