Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening

NCT06060288 | Unknown

• 1 other identifier: 14081996
• Study Type: observational
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of study is to evaluate the sensitivity and specificity of using mobile phone photographs versus conventional clinical examination as a screening tool for early detection of oral cancer.

Conditions

Premalignant Lesion; Oral Cancer

Keywords

teledentistry; oral cancer screening; oral potentially malignant lesions

Outcome Measures

Primary Outcomes (1)

• Categorization of oral mucosal lesions

  to categorize the oral lesions into: 1. Normal variance 2. Reactive or inflammatory lesions 3. Potentially malignant lesions 4. Oral cancer

  one year

Secondary Outcomes (1)

• Referral decision

  one year

Interventions

Diagnosis by mobile phone imaging DIAGNOSTIC_TEST

The photographs will be taken with a smartphone iPhone 14 Pro in a one-year period. Imaging will follow the recommendations regarding intraoral photography in oral mucosal screening set by (Lin et al., 2021). Personal data and a brief description of the present illness concerning the main complaint will be informed by the patients and recorded in a diagnosis chart of the Oral medicine department Cairo University. Complete intraoral physical examination will be performed by the main investigator under supervision of the main supervisor and the co-supervisor using dental equipment with artificial light.

Also known as: smartphone iPhone 14 Pro

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- Patients have any visible oral mucosal lesions including normal variants, reactive and inflammatory lesions and potentially malignant lesions (PML)

You may qualify if:

• Patients have any visible oral mucosal lesions including:
• Normal Variants
• Reactive and inflammatory lesions
• Potentially malignant lesions (PML)
• Oral cancer

You may not qualify if:

• \- 1. Patients unable to open their mouth properly due to trismus, pain, fibrosis or scleroderma.
• \. Patients unable to follow instructions such as mental disability and children below 12-year-old.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• Haron N, Zain RB, Nabillah WM, Saleh A, Kallarakkal TG, Ramanathan A, Sinon SH, Razak IA, Cheong SC. Mobile Phone Imaging in Low Resource Settings for Early Detection of Oral Cancer and Concordance with Clinical Oral Examination. Telemed J E Health. 2017 Mar;23(3):192-199. doi: 10.1089/tmj.2016.0128. Epub 2016 Aug 19.

  PMID: 27541205 BACKGROUND

• Lin I, Datta M, Laronde DM, Rosin MP, Chan B. Intraoral Photography Recommendations for Remote Risk Assessment and Monitoring of Oral Mucosal Lesions. Int Dent J. 2021 Oct;71(5):384-389. doi: 10.1016/j.identj.2020.12.020. Epub 2021 Feb 20.

  PMID: 33618833 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mary F Mikhail, TA

  master candidate in Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary F Mikhail, TA

CONTACT

00201091026115; mary.mikhail@dentistry.cu.edu.eg

Salsabeel A Afifi, Lecturer

CONTACT

sam24@fayoum.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor in Department of Oral Medicine ,diagnosis and Periodontology , Faculty of Dentistry Fayoum University

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: September 29, 2023
• Study Start: October 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 3, 2023

Record last verified: 2023-09