NCT01915797

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
998

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

9.5 years

First QC Date

August 2, 2013

Last Update Submit

February 11, 2026

Conditions

Keywords

Pediatric patients, tumor, developmental abnormalities

Outcome Measures

Primary Outcomes (1)

  • Registration of developmental abnormalities in pediatric patients with cancer retrospectively and prospectively for a period of three years on a nationwide scale

    Day 0

Secondary Outcomes (2)

  • to record tumoral pathologies in known contexts of cancer predisposition

    Day 0

  • to record tumoral pathologies occurring in association with one or more developmental anomaly, these associations might have been already described or not

    Day 0

Study Arms (1)

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

Interventions

all tumor pathology associated with anomaly of development

Patient having a cancer and abnormal development

Eligibility Criteria

Age0 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patient having developed a cancerous pathology and presenting one or several anomalies of the development.

You may qualify if:

  • \- 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

  • Semeraro M, Fouquet C, Vial Y, Amiel J, Galmiche L, Cretolle C, Blanc T, Jolaine V, Garcelon N, Entz-Werle N, Pellier I, Verite C, Sophie Taque, Coulomb A, Petit A, Corradini N, Bouazza N, Lacour B, Clavel J, Brugieres L, Bourdeaut F, Sarnacki S; members of the TED Consortium. Pediatric Tumors and Developmental Anomalies: A French Nationwide Cohort Study. J Pediatr. 2023 Aug;259:113451. doi: 10.1016/j.jpeds.2023.113451. Epub 2023 May 9.

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Sabine SARNACKI, MD, PhD

    Groupement Hospitalier Necker 149 rue de Sèvres 75015 PARIS France

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 5, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations