search
Back to results

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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intraepithelial Carcinoma focused on measuring Colposcopy, oral epithelial dysplasia, diagnostic accuracy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    March 6, 2017
    Last Updated
    March 8, 2017
    Sponsor
    Cairo University
    search

    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

    We'll reach out to this number within 24 hrs