Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tumor and Development (TED) (TED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 2, 2013
First Posted Date August 5, 2013
Last Update Posted Date June 29, 2021
Actual Study Start Date June 1, 2013
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 2, 2013)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 2, 2013)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tumor and Development (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
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient having developed a cancerous pathology and presenting one or several anomalies of the development.
Condition Tumor and Abnormalities of the Development
Intervention Other: blood and tumor samples
all tumor pathology associated with anomaly of development
Study Groups/Cohorts Patient having a cancer and abnormal development
Patient having developed a cancerous pathology and presenting one or several anomalies of the development.
Intervention: Other: blood and tumor samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 26, 2021)
1000
Original Estimated Enrollment
 (submitted: August 2, 2013)
300
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01915797
Other Study ID Numbers NI11049
AOM 11319
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Study Director: Sabine SARNACKI, MD/PHD Groupement Hospitalier Necker 149 rue de Sèvres 75015 PARIS France
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date June 2021