Clinical trial
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 -
Name
IC 2014-01
Description
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.
Trial arms
Trial start
2014-09-01
Estimated PCD
2021-01-01
Trial end
2021-01-01
Status
Completed
Treatment
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.
Arms:
Tumoral specific genetic alterations
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).
Arms:
Tumoral specific genetic alterations
Size
30
Primary endpoint
Detection by Polymerase Chain Reaction (PCR) of specific genetic alterations
at the inclusion
Detection of specific genetic alterations of tumoral cells in peripheral samples
Up to 6 years
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-01-31
1 organization
1 product
1 indication
Organization
Institut Curie