Confrontation Phenotypes and Genotypes of Epithelial Odontogenic Tumors of the Jaws

Completed

• Conditions: Epithelial Odontogenic Tumours

• Registration Number: NCT02167581
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-19
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-23
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 319

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phenotypic and genotypic lines connected to the epithelial odontogenic tumours	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

Trial Locations

Locations (1)

Stomatologie et Chirurgie Maxillofaciale - Pitie Salpetriere; 🇫🇷 Paris, France