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Analyse of Tumour and Constitutional DNA for the Study of the Determinism in Child Neoplasia (ALADIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04471961
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : March 15, 2021
Sponsor:
Collaborator:
Soroptimist association of Monaco
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Background. Cancer is the leading cause of death by disease in children. Most pediatric tumors differ from adult tumors in terms of biological and clinical characteristics. In children, the part of genetic determinism could be higher since the role of environmental factors may be less pronounced than in adults and that a young age at onset is a main feature of genetic cancer predisposition. Recent studies suggested that a number of genetic predisposition remains to be characterized.

Methods. Trio-Based whole exome sequencing of germline DNA from patients (children and adults diagnosed with cancers between 0 and 17 years) and parents will be performed prospectively in a multicentric study including 40 unselected cases of malignant tumor. Participating hospitals will include the CHU of Montpellier, the CHU de Nice and the AP-HP. Tumor analysis will include whole exome analysis and transcriptome for the identification of therapeutic target and contribute to confirm potential link between constitutive mutations and tumor phenotype (such as loss of expression, loss of heterozygosity).

Perspectives. This pediatric oncology study proposing a global approach integrating trio-based whole exome sequencing, somatic DNA and RNA analysis will improve the recognition of genetic predisposition and the characterization of target therapies in children with cancer.


Condition or disease Intervention/treatment Phase
Pediatric Tumor Familial Cancer Solid Tumor, Childhood Hematological Tumor Genetic: Exome sequencing in pediatrics cancers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Analyse of Tumour and Constitutional DNA for the Study of the Determinism in Child Neoplasia
Actual Study Start Date : July 9, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Children with cancer (Proband) with theirs parents Genetic: Exome sequencing in pediatrics cancers
This pediatric oncology study proposing a global approach integrating trio-based whole exome sequencing, somatic DNA and RNA analysis will improve the recognition of genetic predisposition and the characterization of target therapies in children with cancer.




Primary Outcome Measures :
  1. Identification of genetic variants and confirmation of the causality of these variants for the patient's pathology whole exome sequencing [ Time Frame: 12 months ]

    A blood sample will be taken from patients and their parents in order to carry out genetic analyses.

    New generation NGS Exome sequencing in trio (patient and 2 healthy parents) on an Illumina HiSeq 2000 platform using the SureSelectXT Human All Exon 50Mb, V5 kit.

    Bioinformatics analysis of the data. Confirmation of mutations by Sanger sequencing (gold standard).

    In case of identification of mutations in candidate genes confirmed by Sanger sequencing, we will perform functional and clinical-genetic studies.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has a solid or haematological malignancy, either familial forms or isolated cases diagnosed between the ages of 0 and 17 years.
  • The minor patient and both biological parents are available to participate in the study OR
  • The adult patient and one or both parents are available to participate in the study.
  • The patient's parents must have given their free and informed consent and signed the consent for the minor's participation in the study.
  • The patient's parent(s) must have given free and informed consent and the patient of legal age must have signed the consent for participation in the study.
  • The patient must be affiliated or beneficiary of a Frrench social security scheme.

Exclusion Criteria:

  • The patient's parents are under guardianship or trusteeship or under legal protection Yes No
  • Failure to obtain written informed consent from parents (for themselves and their minor child) after a period of reflection Yes No
  • No affiliation to or beneficiary of a French social security scheme (for biological parents and the patient)

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): NCT04471961


Contacts
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Contact: Pascal Pujol, PU-PH +33 4 67 33 58 75 p-pujol@chu-montpellier.fr

Locations
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France
CHU Montpellier Recruiting
Montpellier, Occitanie, France, 34295
Contact: Pascal Pujol, PU-PH    04 67 33 58 75 ext 33    p-pujol@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Soroptimist association of Monaco
Investigators
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Principal Investigator: Pascal Pujol, PU-PH Montpellier University Hospital
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04471961    
Other Study ID Numbers: RECHMPL 19_0519
2020-A0298-31 ( Other Identifier: IDRCB )
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Pediatric oncology
Exome based trio
Cancer predisposition gene
Target therapies
Tumor exome
Transcriptome
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases