Clinical trial NCT03075098: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Intraepithelial Carcinoma
Keywords: Colposcopy
oral epithelial dysplasia
diagnostic accuracy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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:

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.

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.

Primary outcomes:
measure: Diagnostic accuracy of colposcopic examination
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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