Intraepithelial CarcinomaNCT03075098
Colposcopy in Detection of Oral Epithelial Dysplasia
A study testing Digital colposcope in people with Intraepithelial Carcinoma, run by Cairo University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intraepithelial Carcinoma
- What is being tested?
- Digital colposcope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients seeking for diagnosis of clinically suspected oral dysplastic Leukoplakia or Erythroplakia
- Patients seeking for diagnosis of clinically suspected oral Carcinoma.
Who cannot join
- Patients with secondary infection.
- Patients having other systemic diseases.
- Patients undergoing treatment for the lesions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraepithelial Carcinoma
- Being tested
- Digital colposcope
- Keywords
- Colposcopy, oral epithelial dysplasia, diagnostic accuracy
- Medical subject headings
- Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital colposcopeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| colposcopy of intraepithelial carcinoma | Experimental | Digital colposcope will be used to detect the swede score of the lesion Receives: Device: Digital colposcope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of colposcopic examination
using digital colposcope (Kernel, KN-2200, China)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startJun 2017 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraepithelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah badway, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075098
- Sponsor's protocol ID
- CEBD-CU-2017-03-1
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy Of Colposcopic Examination in Patients With Oral Dysplastic Lesion (Diagnostic Accuracy Study)
- ClinicalTrials.gov ID
- NCT03075098
- Acronym / sponsor ID
- CEBD-CU-2017-03-1
- Conditions
- Intraepithelial Carcinoma
- Keywords
- Colposcopy, oral epithelial dysplasia, diagnostic accuracy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colposcopy of intraepithelial carcinoma | Experimental | Device: Digital colposcopeDigital colposcope will be used to detect the swede score of the lesion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients seeking for diagnosis of clinically suspected oral dysplastic Leukoplakia or Erythroplakia
- Patients seeking for diagnosis of clinically suspected oral Carcinoma.
Key exclusion criteria (3 listed)
- Patients with secondary infection.
- Patients having other systemic diseases.
- Patients undergoing treatment for the lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital colposcopeDiagnostic 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. | Device | colposcopy of intraepithelial carcinoma |
Primary outcome
Diagnostic accuracy of colposcopic examination
Time frame: Baseline
using digital colposcope (Kernel, KN-2200, China)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Digital colposcope in people with Intraepithelial Carcinoma, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah A Mohamed, Master (01119742598, sarah.badawy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of colposcopic examination (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.