Diagnostic Accuracy of Salivary DNA Integrity Index in Oral Malignant and Premalignant Lesions

NCT03682562 | Completed DMC

• 1 other identifier: N1P1H1D1
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to identify the accuracy of DNA integrity index in differentiating between oral premalignant lesions and oral cancer.

Conditions

Oral Cancer; Oral Lichen Planus; Oral Leukoplakia

Outcome Measures

Primary Outcomes (1)

• Difference in DNA Integrity Index

  The DNA integrity will be compared between the three group to determine whether there is a difference between them in that aspect or not

  1 month after the end of patient recruitment

Study Arms (3)

Oral Cancer

Patients diagnosed clinically and histopathologically as having oral cancer.

Diagnostic Test: DNA Integrity Index

Premalignant Oral Lesions

Patients diagnosed clinically and histopathologically with either leukoplakia or oral lichen planus as stated by modified WHO criteria

Diagnostic Test: DNA Integrity Index

Normal Subjects

Patients who give a history of: * No smoking * No alcohol * No systemic disease; and who on conventional oral examination have: * No visible oral lesions on conventional oral examination . * Good oral hygiene.

Diagnostic Test: DNA Integrity Index

Interventions

DNA Integrity Index DIAGNOSTIC_TEST

This test will be performed for ALL three groups: Sample collection: Patients will be given a sterile cup containing 5mL saline solution with which they will vigorously rinse their mouth while rubbing their tongues against the oral mucosa for 30 seconds, then spit it back into the cup. The solution will then be used for DNA extraction. DNA integrity analysis: The DNA integrity will be done through measuring a housekeeping gene using competitive polymerase chain reaction where the isolated DNA will be combined with DNA capture probes for sequence-specific DNA fragments. The DNA integrity index will be calculated as the ratio of the concentration of longer DNA fragments to the ratio of shorter ones.

Normal Subjects; Oral Cancer; Premalignant Oral Lesions

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group I: (Clinical examination and Biopsy) Patients diagnosed clinically and histopathologically as having oral cancer. Group II: (History and Clinical examination) Patients who give a history of: * No smoking * No alcohol * No systemic disease; and who on conventional oral examination(National Institute of Dental and Craniofacial Research, 2013b) have: * No visible oral lesions on conventional oral examination . * Good oral hygiene. Group III: (Clinical examination and Biopsy) Patients diagnosed clinically and histopathologically with oral lichen planus as stated by modified WHO criteria (van der Meij and van der Waal, 2003).

You may qualify if:

• No visible oral lesions as detected by conventional oral examination
• Good oral hygiene, with healthy gingival tissues
• Non-smokers
• No systemic disease Group III: Patients diagnosed with oral lichen planus according to the modified WHO (van der Meij and van der Waal, 2003)diagnostic criteria not receiving treatment at least 8 weeks prior to enrollment.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, 11553, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

Salivary Samples will be obtained for DNA extraction, Biosamples will be stored in -80 degrees after patient's consent

MeSH Terms

Conditions

Mouth Neoplasms; Lichen Planus, Oral; Leukoplakia, Oral

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Leukoplakia; Precancerous Conditions; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 24, 2018
• Study Start: September 15, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

EG (1)