Clinical trial NCT02167581: Confrontation Phenotypes and Genotypes of Epithelial Odontogenic Tumors of the Jaws
Official title: Confrontation Phenotypic (Clinical, Radiological, Histological) and Genotypic Epithelial Odontogenic Tumors Isolated or Syndromic Jaws
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelial Odontogenic Tumours
Keywords: Maxillofacial surgery
Epithelial odontogenic tumours
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 319
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with an osteolytic lesion of the jaws resulting of an epithelial odontogenic tumor

Brief summary: 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.

Detailed description: 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 :

1. st center is in the service of Stomatology and Maxillofacial Surgery in the Pitie Salpetriere Hospital.
2. 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.

Eligibility criteria: Inclusion criteria

1. Patient with an osteolytic lesion of the jaws
2. Patient with epithelial odontogenic tumor:

   keratocysts ameloblastoma Pindborg tumor or calcifying (ESWT) Epidermoid (Squamous Odontogenic Tumor SOT) Clear cell (Clear Odontogenic Tumor Cells CCOT)
3. Patient monitoring in the period 1992 to January 2011 at the Trousseau Hospital (children) or at the Pitie Salpetriere (adult)
4. Patient aged 5 years or more
5. Adult patient who had signed informed consent
6. Holders of parental authority of minor patient were informed and signed consent

Non inclusion criteria

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

Primary outcomes:
measure: Phenotypic and genotypic lines connected to the epithelial odontogenic tumours
timeFrame: Month 24 from the surgery date
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Stomatologie et Chirurgie Maxillofaciale - Pitie Salpetriere
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Blandine Ruhin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: