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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumoral specific genetic alterations | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumoral specific genetic alterations | Biological | A buccal swab and a blood sample will be used at the diagnostic to identify the specific genetic alterations of tumoral cells. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Neuroblastoma, sarcoma, malignant brain tumor (medulloblastoma, high-grade glioma), bone tumors, rhabdoid tumors, others rare tumors
Exclusion Criteria :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie | Paris | 75005 | France |
Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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| Tumoral specific genetic alterations | Biological | 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). |
|
| Up to 6 years |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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