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

NCT ID: NCT02546453

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2021-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic and/or High Risk Solid Tumor of Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Tumoral specific genetic alterations

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.

Group Type OTHER

Tumoral specific genetic alterations

Intervention Type BIOLOGICAL

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

Intervention Type 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).

Interventions

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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.

Intervention Type BIOLOGICAL

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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Curie

Paris, , France

Site Status

Countries

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France

Other Identifiers

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IC 2014-01

Identifier Type: -

Identifier Source: org_study_id

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