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History of Changes for Study: NCT01915797
Tumor and Development (TED) (TED)
Latest version (submitted June 26, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 2, 2013 None (earliest Version on record)
2 July 25, 2014 Study Status
3 April 9, 2015 Study Status and Study Design
4 November 25, 2015 Study Status and Study Design
5 August 25, 2016 Study Status
6 December 20, 2017 Study Status, Study Design and Conditions
7 June 26, 2021 Study Status, Contacts/Locations, Eligibility and Study Design
Comparison Format:

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Study NCT01915797
Submitted Date:  August 2, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: NI11049
Brief Title: Tumor and Development (TED) (TED)
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
Secondary IDs: AOM 11319
Open or close this module Study Status
Record Verification: July 2013
Overall Status: Recruiting
Study Start: June 2013
Primary Completion: June 2016 [Anticipated]
Study Completion: June 2017 [Anticipated]
First Submitted: August 2, 2013
First Submitted that
Met QC Criteria:
August 2, 2013
First Posted: August 5, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 2, 2013
Last Update Posted: August 5, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Assistance Publique - Hôpitaux de Paris
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
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
Open or close this module Conditions
Conditions: Patient Having Developed a Cancerous Pathology and Presenting One or Several Anomalies of the Development.
Keywords: Pediatric patients, tumor, developmental abnormalities
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective:
Biospecimen Retention:
Biospecimen Description:
Enrollment: 300 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Patient having a cancer and abnormal development
Patient having developed a cancerous pathology and presenting one or several anomalies of the development.
blood and tumor samples
all tumor pathology associated with anomaly of development
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Study Population: Patient having developed a cancerous pathology and presenting one or several anomalies of the development.
Sampling Method: Non-Probability Sample
Minimum Age:
Maximum Age: 18 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.

Open or close this module Contacts/Locations
Central Contact Person: Sabine SARNACKI, MD/PHD
Telephone: +33 1 44 49 41 94
Email: sabine.sarnacki@nck.aphp.fr
Central Contact Backup: Laurence Lecomte, PhD
Telephone: +33 1 71 19 64 94
Email: laurence.lecomte@nck.aphp.fr
Study Officials: Sabine SARNACKI, MD/PHD
Study Director
Groupement Hospitalier Necker 149 rue de Sèvres 75015 PARIS France
Locations: France
Hôpital Necker Enfants Malades
[Recruiting]
Paris, France, 75015
Contact:Contact: Sabine SARNACKI, MD/PHD +33 1 44 49 41 94 sabine.sarnacki@nck.aphp.fr
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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