Colposcopy in Detection of Oral Epithelial Dysplasia
Primary Purpose
Intraepithelial Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Digital colposcope
Sponsored by
About this trial
This is an interventional diagnostic trial for Intraepithelial Carcinoma focused on measuring Colposcopy, oral epithelial dysplasia, diagnostic accuracy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
colposcopy of intraepithelial carcinoma
Arm Description
Digital colposcope will be used to detect the swede score of the lesion
Outcomes
Primary Outcome Measures
Diagnostic accuracy of colposcopic examination
using digital colposcope (Kernel, KN-2200, China)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03075098
Brief Title
Colposcopy in Detection of Oral Epithelial Dysplasia
Official Title
Diagnostic Accuracy Of Colposcopic Examination in Patients With Oral Dysplastic Lesion (Diagnostic Accuracy Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraepithelial Carcinoma
Keywords
Colposcopy, oral epithelial dysplasia, diagnostic accuracy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
colposcopy of intraepithelial carcinoma
Arm Type
Experimental
Arm Description
Digital colposcope will be used to detect the swede score of the lesion
Intervention Type
Device
Intervention Name(s)
Digital colposcope
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic accuracy of colposcopic examination
Description
using digital colposcope (Kernel, KN-2200, China)
Time Frame
Baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah A Mohamed, Master
Phone
01119742598
Email
sarah.badawy@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Colposcopy in Detection of Oral Epithelial Dysplasia
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