Confrontation Phenotypes and Genotypes of Epithelial Odontogenic Tumors of the Jaws (TEIOS)

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

Study Overview

• Status: Completed
• Conditions: Epithelial Odontogenic Tumours

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.

• Study Type: Observational
• Enrollment (Actual): 319

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Stomatologie et Chirurgie Maxillofaciale - Pitie Salpetriere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with an osteolytic lesion of the jaws resulting of an epithelial odontogenic tumor

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
epithelial odontogenic tumours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phenotypic and genotypic lines connected to the epithelial odontogenic tumours	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	Month 24 from the surgery date

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Blandine Ruhin, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (ESTIMATE): June 19, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 24, 2015
• Last Update Submitted That Met QC Criteria: April 23, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Maxillofacial surgery; Epithelial odontogenic tumours
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Odontogenic Tumors
• Other Study ID Numbers: P081259