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Completed

NCT Number: NCT02546453

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

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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Key information

Conditions

Metastatic and/or High Risk Solid Tumor of Children Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie

Paris, 75005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. Detection of genetic alterations in solid tumor pediatric samples

    Time frame: At the inclusion

    Use of identified genetic alterations in solid tumor pediatric samples to help to confirm diagnosis and prognosis and to search for new therapeutic targets

  2. 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

    Time frame: Up to 6 years

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study 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 -

Acronym: NGSKids

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2015
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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