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Completed

NCT Number: NCT02167581

Confrontation Phenotypes and Genotypes of Epithelial Odontogenic Tumors of the Jaws

Systematically compare the phenotype and genotype of epithelial odontogenic tumors in children and adults with a clinical, radiographic, pathologic and molecular level.

Either:

establish an observatory of this multidisciplinary tumor establish a tumor bank annotated scale unparalleled testing pathophysiological hypotheses search for prognostic factors.

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stomatologie et Chirurgie Maxillofaciale - Pitie Salpetriere

Paris, 75013, France

About this study

This is an observational study with retrospective and prospective parts. In retrospective part be included the Patients followed between 1992 and January 2011.

In prospective part will follow the Patients will be included after the starting of study.

There are 2 centers :

  • st center is in the service of Stomatology and Maxillofacial Surgery in the Pitie Salpetriere Hospital.
  • nd center is in the service of Maxillofacial Surgery in hospital Armand Trousseau.

Number of patients include in the part retrospective :

Center N°1-300adults Center N°2-90childrens

Number of patients include in the part prospective :

Center N°1- 90 Center N°2- 30

Duration of study is 3 years Duration of inclusion is 32 months Each patient will be followed for 4 months and for further up to 3 years from the first patient included.

We envision a next circuit : obtaining consent, preoperative consultation,surgery, postoperative consultation N°1, postoperative consultation N°2, genetics consultation and monitoring of patients in 6;12;18;24 months from surgery of tumor and limited in 3 years from th 1st patient included.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with an osteolytic lesion of the jaws
  • Patient with epithelial odontogenic tumor:

keratocysts ameloblastoma Pindborg tumor or calcifying (ESWT) Epidermoid (Squamous Odontogenic Tumor SOT) Clear cell (Clear Odontogenic Tumor Cells CCOT)

  • Patient monitoring in the period 1992 to January 2011 at the Trousseau Hospital (children) or at the Pitie Salpetriere (adult)
  • Patient aged 5 years or more
  • Adult patient who had signed informed consent
  • Holders of parental authority of minor patient were informed and signed consent

Non inclusion criteria

  • Patient with an osteolytic lesion of dental origin inflammatory (adjacent teeth decayed, non-living mortified)
  • Patient with a cyst fissure (nasopalatine, symphyseal or globulomaxillary)
  • Patient with arteriovenous malformation, vascular
  • Patient with cons-indication to MRI
  • Patient not affiliated with a social security scheme (beneficiary or assignee)
  • Pregnant woman
  • Patient in his history of hypersensitivity to salts of gadolinium
  • Patient receiving a measure of legal protection

Treatment and study plan

Primary outcomes

  1. Phenotypic and genotypic lines connected to the epithelial odontogenic tumours

    Time frame: Month 24 from the surgery date

    In particular, to define the link between the genotype PTCH1, the size of the tumor, its osteolytic character and the predictive factors of recurrence.

    Data collection at M6, M12, M18, M24 from the surgery date

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Confrontation Phenotypic (Clinical, Radiological, Histological) and Genotypic Epithelial Odontogenic Tumors Isolated or Syndromic Jaws

Acronym: TEIOS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2014
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.