Colposcopy in Detection of Oral Epithelial Dysplasia

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03075098

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this work is to detect the diagnostic accuracy of the intra-oral application of colposcope in diagnosing oral dysplastic lesions in comparison to biopsy taking and histopathological examination.

Condition or Disease	Intervention/Treatment	Phase
Intraepithelial Carcinoma	Device: Digital colposcope	N/A

Detailed Description

A- Roles and Responsibilities:

The Principle Supervisor: Dr. Mohsen Kazem (M.K.), Professor of Oral &Maxillofacial Pathology, Cairo University, will examine the taken biopsy histopathologically and determine the definitive diagnosis.
The Assistant Supervisor: Dr. Heba Dahmoush (H.D.), Professor of Oral & Maxillofacial Pathology, Cairo University, will examine the taken biopsy histopathologically and determine the definitive diagnosis.
The Principle Investigator: Sarah Ahmed Mohamed Mahmoud Badawy (S.B.), Assistant Lecturer of Oral &Maxillofacial Pathology, Cairo University, will read and put a colposcopic score for each participant individually.
Eman Desouky (E.D.) Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
Evidence Based Committee, Faculty of Dentistry, Cairo University: Help in reporting study protocol following STARD guidelines.
Ethics Committee, Faculty of Dentistry, Cairo University: Protocol reviewer of the diagnostic accuracy study in order to protect the right, safety, dignity and well-being of the participants.

B- Index test: The principle investigator (S.B.) will perform the index test using Digital Electronic Colposcope (Kernel, KN-2200, China). Before taking up the patients for Colposcopic evaluation and giving them a score, the normal Colposcopic findings will be standardized based on the Colposcopic criteria. Colposcopic criteria includes aceto uptake, surface pattern and clarity of demarcation of the mucosal lesions, vascular pattern, lesion size as well as Iodine staining.

C- Reference test:The reference standard; to reach a definitive diagnosis in oral dysplastic lesions, will be a representative biopsy and histopathological examination. M.K. and H.D. will examine the taken biopsy histopathologically, determine the definitive diagnosis and write the diagnosis in the Assessor chart.

Inclusion criteria:

Patients seeking for diagnosis of clinically suspected oral dysplastic Leukoplakia or Erythroplakia
Patients seeking for diagnosis of clinically suspected oral Carcinoma.

Exclusion criteria:

Patients with secondary infection.
Patients having other systemic diseases.
Patients undergoing treatment for the lesions.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Diagnostic Accuracy Of Colposcopic Examination in Patients With Oral Dysplastic Lesion (Diagnostic Accuracy Study)

Anticipated Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: colposcopy of intraepithelial carcinoma Digital colposcope will be used to detect the swede score of the lesion	Device: Digital colposcope Diagnostic accuracy of colposcopic examination; Swede scoring system will be used to evaluate the colposcopic examination. Then, the specificity (%) and the sensitivity (%) of colposcopic examination will be calculated using the cutoff value of 8 to segregate dysplastic from non-dysplastic lesions.

Arm

Intervention/Treatment

Experimental: colposcopy of intraepithelial carcinoma

Digital colposcope will be used to detect the swede score of the lesion

Device: Digital colposcope

Diagnostic accuracy of colposcopic examination; Swede scoring system will be used to evaluate the colposcopic examination. Then, the specificity (%) and the sensitivity (%) of colposcopic examination will be calculated using the cutoff value of 8 to segregate dysplastic from non-dysplastic lesions.

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy of colposcopic examination [Baseline]
using digital colposcope (Kernel, KN-2200, China)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients seeking for diagnosis of clinically suspected oral dysplastic Leukoplakia or Erythroplakia
Patients seeking for diagnosis of clinically suspected oral Carcinoma.

Exclusion Criteria:

Patients with secondary infection.
Patients having other systemic diseases.
Patients undergoing treatment for the lesions.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sarah badway, assistant lecturer, oral & maxillofacial pathology department, cairo university, Cairo University

ClinicalTrials.gov Identifier:

NCT03075098

Other Study ID Numbers:

CEBD-CU-2017-03-1

First Posted:

Mar 9, 2017

Last Update Posted:

Mar 9, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sarah badway, assistant lecturer, oral & maxillofacial pathology department, cairo university, Cairo University

Colposcopy

oral epithelial dysplasia

diagnostic accuracy

Additional relevant MeSH terms:

Carcinoma in Situ

Study Results

No Results Posted as of Mar 9, 2017