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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment
Tumor and Abnormalities of the Development Other: blood and tumor samples

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

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
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


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. to record tumoral pathologies in known contexts of cancer predisposition [ Time Frame: Day 0 ]
  2. 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 ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient having developed a cancerous pathology and presenting one or several anomalies of the development.
Criteria

Inclusion Criteria :

- 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

Exclusion Criteria:

  • 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.


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): NCT01915797


Contacts
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Contact: Sabine SARNACKI, MD/PHD +33 1 44 49 41 94 sabine.sarnacki@nck.aphp.fr
Contact: Valérie JOLAINE 00 33 1 42 19 28 79 valerie.jolaine@aphp.fr

Locations
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France
Hôpital Necker Enfants Malades Recruiting
Paris, France, 75015
Contact: Sabine SARNACKI, MD/PHD    +33 1 44 49 41 94    sabine.sarnacki@nck.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Sabine SARNACKI, MD/PHD Groupement Hospitalier Necker 149 rue de Sèvres 75015 PARIS France
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01915797    
Other Study ID Numbers: NI11049
AOM 11319
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pediatric patients, tumor, developmental abnormalities
Additional relevant MeSH terms:
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Congenital Abnormalities