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Trial record 2 of 17516 for:    Genetic AND Genetics

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 (NGSKids)

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ClinicalTrials.gov Identifier: NCT02546453
Recruitment Status : Recruiting
First Posted : September 10, 2015
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic and/or High Risk Solid Tumor of Children Biological: Tumoral specific genetic alterations Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 -
Actual Study Start Date : September 2014
Actual Primary Completion Date : November 17, 2014
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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.
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.

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).




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546453


Contacts
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Contact: Gudrun SCHLEIERMACHER, DR gudrun.schleiermacher@curie.fr

Locations
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France
Institut Curie Recruiting
Paris, France, 75005
Contact: Gudrun SCHLIEIRMACHER, DR       gudrun.schlieirmacher@curie.fr   
Principal Investigator: Gudrun SCHLIEIRMACHER, DR         
Sponsors and Collaborators
Institut Curie

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02546453     History of Changes
Other Study ID Numbers: IC 2014-01
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by Institut Curie:
high risk solid tumor pediatric, genetic alteration, Metastatic solid tumor pediatric

Additional relevant MeSH terms:
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Neoplasms