Etude : Tumor and Development (TED) /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : Tumor and Development (TED)

Nom :

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 05/03/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Identification of Patients/Families With a Paediatric Tumor and One or More Developmental Abnormalities - Characterization of New Tumor Predisposition Syndromes and Study of Their Molecular Basis

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C96 - Tumeurs malignes des tissus lymphoïde, hématopoïétique et apparentés, autres et non précisées

Spécialité : Toutes tumeurs solides
Localisation : C - Toutes localisations
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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

Phase : NA

Stade : NA

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - 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
* 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

Critères de non-inclusion : - 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.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT01915797
Promoteur :
APHP
Type de sponsor : Institutionnel
APHP
75010 PARIS 10

Coordonnateur :
Professeur Sabine SARNACKI
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur Anne LAMBILLIOTTE

TEC / ARC / IDE :
Amandine GORALSKI
amandine.goralski@
chru-lille.fr
03.20.44.60.58

Statut de l'essai : OUVERT

MAJ : 13/12/2019