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Clinical Trials/NCT02546453
NCT02546453
Completed
N/A

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 -

Institut Curie1 site in 1 country30 target enrollmentSeptember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Metastatic and/or High Risk Solid Tumor of Children
Sponsor
Institut Curie
Enrollment
30
Locations
1
Primary Endpoint
Detection by Polymerase Chain Reaction (PCR) of specific genetic alterations
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
January 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Detection by Polymerase Chain Reaction (PCR) of specific genetic alterations

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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