Epithelial Odontogenic TumoursTEIOSNCT02167581
Confrontation Phenotypes and Genotypes of Epithelial Odontogenic Tumors of the Jaws
An observational study of Epithelial Odontogenic Tumours, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Epithelial Odontogenic Tumours
- How many people
- 319 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with an osteolytic lesion of the jaws resulting of an epithelial odontogenic tumor
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Stomatologie et Chirurgie Maxillofaciale - Pitie Salpetriere
Paris, 75013
About this study
Official title: 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.
Read the 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 :
- 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.
- Conditions
- Epithelial Odontogenic Tumours
- Keywords
- Maxillofacial surgery, Epithelial odontogenic tumours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| epithelial odontogenic tumours | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 24 from the surgery date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJan 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Odontogenic TumoursStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blandine Ruhin, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167581
- Sponsor's protocol ID
- P081259
- Acronym
- TEIOS
- Status last verified
- Apr 2015
- First submitted
- 13 Jun 2014
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confrontation Phenotypic (Clinical, Radiological, Histological) and Genotypic Epithelial Odontogenic Tumors Isolated or Syndromic Jaws
- ClinicalTrials.gov ID
- NCT02167581
- Acronym / sponsor ID
- TEIOS / P081259
- Conditions
- Epithelial Odontogenic Tumours
- Keywords
- Maxillofacial surgery, Epithelial odontogenic tumours
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epithelial odontogenic tumours | – | – |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with an osteolytic lesion of the jaws resulting of an epithelial odontogenic tumor
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blandine Ruhin, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial Odontogenic Tumours, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypic and genotypic lines connected to the epithelial odontogenic tumours (time frame: Month 24 from the surgery date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.