Pediatric TumorALADINNCT04471961
Analyse of Tumour and Constitutional DNA for the Study of the Determinism in Child Neoplasia
A study testing Exome sequencing in pediatrics cancers in people with Pediatric Tumor and Familial Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Tumor, Familial Cancer, Solid Tumor, Childhood
- What is being tested?
- Exome sequencing in pediatrics cancers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2020to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Exome sequencing in pediatrics cancers
- Keywords
- Pediatric oncology, Exome based trio, Cancer predisposition gene, Target therapies, Tumor exome, Transcriptome
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exome sequencing in pediatrics cancersGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with cancer (Proband) with theirs parents | Experimental | Not described Receives: Genetic: Exome sequencing in pediatrics cancers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of genetic variants and confirmation of the causality of these variants for the patient's pathology whole exome sequencing
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start9 Jul 2020
- Primary completion12 Jun 2025
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Soroptimist association of Monaco
- Responsible party
- Sponsor
- Investigators
- Pascal Pujol, PU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471961
- Sponsor's protocol ID
- RECHMPL19_0519
- Other IDs
- 2020-A0298-31
- Acronym
- ALADIN
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2020
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyse of Tumour and Constitutional DNA for the Study of the Determinism in Child Neoplasia
- ClinicalTrials.gov ID
- NCT04471961
- Acronym / sponsor ID
- ALADIN / RECHMPL19_0519
- Keywords
- Pediatric oncology, Exome based trio, Cancer predisposition gene, Target therapies, Tumor exome, Transcriptome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Soroptimist association of Monaco
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cancer (Proband) with theirs parents | Experimental | Genetic: Exome sequencing in pediatrics cancers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exome sequencing in pediatrics cancersThis 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. | Genetic | Children with cancer (Proband) with theirs parents |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
Related trials for Pediatric Tumor
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Psychological Benefits of a Normalized Camping Experience for Children With Cancer
Pediatric Cancer
Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
RecruitingObservational study
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Pujol, PU-PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exome sequencing in pediatrics cancers in people with Pediatric Tumor and Familial Cancer, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of genetic variants and confirmation of the causality of these variants for the patient's pathology whole exome sequencing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.