Tumor and Abnormalities of the DevelopmentTEDNCT01915797
Tumor and Development (TED)
An observational study of Tumor and Abnormalities of the Development, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The overall project goal is to build a database of childhood cancers associated with developmental anomalies; it aims at identifying new syndromes of genetic predisposition and at enabling the further study of their molecular basis. Read more about this study
- Who is it for?
- Ages 0 days to 18 years
- Conditions the study is for
- Tumor and Abnormalities of the Development
- What is being tested?
- blood and tumor samples
- How many people
- 998 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2013to 1 Dec 2022
- Phase
- Observational
- 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 0 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient having developed a cancerous pathology and presenting one or several anomalies of the development.
Who may be able to join
- Patient who developed before the age of 18 years a solid tumour or a malignant or borderline hemopathy.
- AND
- Presenting one or several abnormality (ies) of the development provided it is not related to the treatment and\or to the disease among:
- organ malformation, familial or not
- neuro-sensory deficit, familial or not
- delay of psychomotor acquisitions
Show all 12Show fewer
- epilepsy (not as a sequelae of the tumour)
- disorder of growth and\or weight and\or of the cranial perimeter
- congenital, sporadic and\or familial endocrine or metabolic disease
- dysmorphy
- Informed consent of patient and parents to this study OR
- tumour predisposition syndrome or developmental abnormality in a familial context, the molecular basis might have been already identified or not
Who cannot join
- absence of malignancy in the index case
- lack of developmental anomalies in the index case or in a related first degree
- abnormal development recognized as acquired (traumatic, toxic, infectious, perinatal…)
- age > 18 years at diagnosis of the tumor
- Lack of informed consent of the legal representatives
- The familial aggregations of cancer without developmental disease are not included in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Patients/Families With a Paediatric Tumor and One or More Developmental Abnormalities - Characterization of New Tumor Predisposition Syndromes and Study Their Molecular Basis
The overall project goal is to build a database of childhood cancers associated with developmental anomalies; it aims at identifying new syndromes of genetic predisposition and at enabling the further study of their molecular basis.
Read the detailed description
Most of the solid cancers arising in the childhood develop from embryonic tissues. The frequent association of paediatric cancers and abnormalities of the development underlines the link between oncogenesis and embryogenesis. However, beside the known malformative syndromes predisposing to one or several types of tumours with a variable penetrance (NF1, Wiedemann-Beckwith, Denys-Drash, Fanconi disease), associations between abnormalities of the development and tumours are badly known and little investigated, and are not listed at present systematically in the registers of child cancers.
The cytogenetic exploration of malformative syndromes associated to tumours historically allowed to describe constitutional chromosomal abnormalities of major interest for the understanding of oncogenesis pathways of the most frequent sporadic tumours (del 11p13 and WT1; del 13q14 and Rb1). So, a rare and even exceptional clinical presentation can enrich the knowledge of a common pathology. Our objective is to analyze in a detailed and multidisciplinary way the largest number of possible cases of unusual presentation associating pediatric Tumor And abnormality of Development (TAD).
Principle objective
- Registration of developmental abnormalities in pediatric patients with cancer retrospectively and prospectively for a period of three years on a nationwide scale Secondary objectives
- to record tumoral pathologies in known contexts of cancer predisposition,
- to record tumoral pathologies occurring in association with one or more developmental anomaly, these associations might have been already described or not
- to identify and locate the biological samples of patients registered in coordination with the national pediatric biobank project
- to characterize the molecular basis of the identified associations between developmental abnormalities and tumors. These molecular studies are not straight included in the present project specifically, but should be further conducted on the basis of the clinical data and thanks to the biobank network.
- a biannual analysis of aggregated data by a steering committee will be done to identify informative associations that warrant further clinical studies and biological data
- Biological studies will be performed in conjunction with local investigators and officials of the local biobank, and in coordination with the operation of BIOCAP
- Being tested
- blood and tumor samples
- Keywords
- Pediatric patients, tumor, developmental abnormalities
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and tumor samplesOther
all tumor pathology associated with anomaly of development
| Study group | Role | What they receive |
|---|---|---|
| Patient having a cancer and abnormal development | Patient having developed a cancerous pathology and presenting one or several anomalies of the development. Receives: Other: blood and tumor samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registration of developmental abnormalities in pediatric patients with cancer retrospectively and prospectively for a period of three years on a nationwide scale
Measured: Day 0
Secondary outcomes (2)
to record tumoral pathologies in known contexts of cancer predisposition
Measured: Day 0
to record tumoral pathologies occurring in association with one or more developmental anomaly, these associations might have been already described or not
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study start1 Jun 2013
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tumor and Abnormalities of the DevelopmentStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 998 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sabine SARNACKI, MD, PhD, Study director, Groupement Hospitalier Necker 149 rue de Sèvres 75015 PARIS France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915797
- Sponsor's protocol ID
- NI11049
- Other IDs
- AOM 11319
- Acronym
- TED
- Status last verified
- Feb 2026
- First submitted
- 2 Aug 2013
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Semeraro M, Fouquet C, Vial Y, Amiel J, Galmiche L, Cretolle C, Blanc T, Jolaine V, Garcelon N, Entz-Werle N, Pellier I, Verite C, Sophie Taque, Coulomb A, Petit A, Corradini N, Bouazza N, Lacour B, Clavel J, Brugieres L, Bourdeaut F, Sarnacki S; members of the TED Consortium. Pediatric Tumors and Developmental Anomalies: A French Nationwide Cohort Study. J Pediatr. 2023 Aug;259:113451. doi: 10.1016/j.jpeds.2023.113451. Epub 2023 May 9.
PubMed 37169337
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Patients/Families With a Paediatric Tumor and One or More Developmental Abnormalities - Characterization of New Tumor Predisposition Syndromes and Study Their Molecular Basis
- ClinicalTrials.gov ID
- NCT01915797
- Acronym / sponsor ID
- TED / NI11049
- Keywords
- Pediatric patients, tumor, developmental abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 998 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 5 Aug 2013 (estimated)
- 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.
The overall project goal is to build a database of childhood cancers associated with developmental anomalies; it aims at identifying new syndromes of genetic predisposition and at enabling the further study of their molecular basis.
Detailed description
Most of the solid cancers arising in the childhood develop from embryonic tissues. The frequent association of paediatric cancers and abnormalities of the development underlines the link between oncogenesis and embryogenesis. However, beside the known malformative syndromes predisposing to one or several types of tumours with a variable penetrance (NF1, Wiedemann-Beckwith, Denys-Drash, Fanconi disease), associations between abnormalities of the development and tumours are badly known and little investigated, and are not listed at present systematically in the registers of child cancers.
The cytogenetic exploration of malformative syndromes associated to tumours historically allowed to describe constitutional chromosomal abnormalities of major interest for the understanding of oncogenesis pathways of the most frequent sporadic tumours (del 11p13 and WT1; del 13q14 and Rb1). So, a rare and even exceptional clinical presentation can enrich the knowledge of a common pathology. Our objective is to analyze in a detailed and multidisciplinary way the largest number of possible cases of unusual presentation associating pediatric Tumor And abnormality of Development (TAD).
Principle objective
- Registration of developmental abnormalities in pediatric patients with cancer retrospectively and prospectively for a period of three years on a nationwide scale Secondary objectives
- to record tumoral pathologies in known contexts of cancer predisposition,
- to record tumoral pathologies occurring in association with one or more developmental anomaly, these associations might have been already described or not
- to identify and locate the biological samples of patients registered in coordination with the national pediatric biobank project
- to characterize the molecular basis of the identified associations between developmental abnormalities and tumors. These molecular studies are not straight included in the present project specifically, but should be further conducted on the basis of the clinical data and thanks to the biobank network.
- a biannual analysis of aggregated data by a steering committee will be done to identify informative associations that warrant further clinical studies and biological data
- Biological studies will be performed in conjunction with local investigators and officials of the local biobank, and in coordination with the operation of BIOCAP
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient having a cancer and abnormal development | – | Other: blood and tumor samplesPatient having developed a cancerous pathology and presenting one or several anomalies of the development. |
Who may qualify
- Ages
- 0 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient having developed a cancerous pathology and presenting one or several anomalies of the development.
Key inclusion criteria (12 listed)
- Patient who developed before the age of 18 years a solid tumour or a malignant or borderline hemopathy.
- AND
- Presenting one or several abnormality (ies) of the development provided it is not related to the treatment and\or to the disease among:
- Informed consent of patient and parents to this study OR
- tumour predisposition syndrome or developmental abnormality in a familial context, the molecular basis might have been already identified or not
Key exclusion criteria (6 listed)
- absence of malignancy in the index case
- lack of developmental anomalies in the index case or in a related first degree
- abnormal development recognized as acquired (traumatic, toxic, infectious, perinatal…)
- age > 18 years at diagnosis of the tumor
- Lack of informed consent of the legal representatives
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 |
|---|---|---|
| blood and tumor samplesall tumor pathology associated with anomaly of development | Other | Patient having a cancer and abnormal development |
Primary outcome
Registration of developmental abnormalities in pediatric patients with cancer retrospectively and prospectively for a period of three years on a nationwide scale
Time frame: Day 0
2 secondary outcomes
to record tumoral pathologies in known contexts of cancer predisposition
Time frame: Day 0
to record tumoral pathologies occurring in association with one or more developmental anomaly, these associations might have been already described or not
Time frame: Day 0
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 13 Feb 2026.
- Results publication: PubMed 37169337Semeraro M, Fouquet C, Vial Y, Amiel J, Galmiche L, Cretolle C, Blanc T, Jolaine V, Garcelon N, Entz-Werle N, Pellier I, Verite C, Sophie Taque, Coulomb A, Petit A, Corradini N, Bouazza N, Lacour B, Clavel J, Brugieres L, Bourdeaut F, Sarnacki S; members of the TED Consortium. Pediatric Tumors and Developmental Anomalies: A French Nationwide Cohort Study. J Pediatr. 2023 Aug;259:113451. doi: 10.1016/j.jpeds.2023.113451. Epub 2023 May 9.
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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.
Sabine SARNACKI, MD, PhD study director
Groupement Hospitalier Necker 149 rue de Sèvres 75015 PARIS France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor and Abnormalities of the Development, run by Assistance Publique - Hôpitaux de Paris 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 12 inclusion and 6 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 13 Feb 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?
Registration of developmental abnormalities in pediatric patients with cancer retrospectively and prospectively for a period of three years on a nationwide scale (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01915797, which also lists 1 linked publication.
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 13 Feb 2026.