Tumor and Development (TED) (TED)
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|ClinicalTrials.gov Identifier: NCT01915797|
Recruitment Status : Recruiting
First Posted : August 5, 2013
Last Update Posted : June 29, 2021
|Condition or disease||Intervention/treatment|
|Tumor and Abnormalities of the Development||Other: blood and tumor samples|
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).
- 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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
|Actual Study Start Date :||June 1, 2013|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Patient having a cancer and abnormal development
Patient having developed a cancerous pathology and presenting one or several anomalies of the development.
Other: blood and tumor samples
all tumor pathology associated with anomaly of development
- 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 ]
- 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 ]
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): NCT01915797
|Contact: Sabine SARNACKI, MD/PHD||+33 1 44 49 41 firstname.lastname@example.org|
|Contact: Valérie JOLAINE||00 33 1 42 19 28 email@example.com|
|Hôpital Necker Enfants Malades||Recruiting|
|Paris, France, 75015|
|Contact: Sabine SARNACKI, MD/PHD +33 1 44 49 41 94 firstname.lastname@example.org|
|Study Director:||Sabine SARNACKI, MD/PHD||Groupement Hospitalier Necker 149 rue de Sèvres 75015 PARIS France|