Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03075098 |
| Other study ID # |
CEBD-CU-2017-03-1 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
March 6, 2017 |
| Last updated |
March 8, 2017 |
| Start date |
June 2017 |
| Est. completion date |
March 2018 |
Study information
| Verified date |
March 2017 |
| Source |
Cairo University |
| Contact |
Sarah A Mohamed, Master |
| Phone |
01119742598 |
| Email |
sarah.badawy[@]dentistry.cu.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
