Colposcopy in Detection of Oral Epithelial Dysplasia

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

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.

Study Overview

• Status: Unknown
• Conditions: Intraepithelial Carcinoma
• Intervention / Treatment: Device: Digital colposcope

Detailed Description

A- Roles and Responsibilities:

1. 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.
2. 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.
3. 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.
4. Eman Desouky (E.D.) Sample size calculation; Statistician, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
5. Evidence Based Committee, Faculty of Dentistry, Cairo University: Help in reporting study protocol following STARD guidelines.
6. 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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of colposcopic examination	using digital colposcope (Kernel, KN-2200, China)	Baseline

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: diagnostic accuracy; Colposcopy; oral epithelial dysplasia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma in Situ
• Other Study ID Numbers: CEBD-CU-2017-03-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No