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

Metastatic and/or High Risk Solid Tumor of Children Clinical Trial

— NGSKids  

Official title:

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 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546453
• Other study ID #: IC 2014-01
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: January 2021

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic and/or High Risk Solid Tumor of Children
• Neoplasms

Intervention

Biological:
• Tumoral 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.
• Tumoral specific genetic alterations
Collection of blood (maximum 9 samples of 3 to 5 ml), bone marrow (maximum 3 samples of 3 to 5 ml) and cerebral spinal fluid (maximum 3 samples 500µl to 1ml).

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection by Polymerase Chain Reaction (PCR) of specific genetic alterations	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.	at the inclusion
Primary	Detection of specific genetic alterations of tumoral cells in peripheral samples	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	Up to 6 years
Secondary	Detection of genetic alterations in solid tumor pediatric samples	Use of identified genetic alterations in solid tumor pediatric samples to help to confirm diagnosis and prognosis and to search for new therapeutic targets	At the inclusion
Secondary	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