Validation of Salivary Proteomic Biomarkers for Early Detection of Oral Cancer in Egyptian Population

NCT06471270 | Completed DMC

• 1 other identifier: BU1612
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The present investigation was conducted on 100 individuals allocated into four groups; 25 healthy controls, 25 patients having OPMDs with dysplasia; 25 patients having OPMDs without dysplasia, and 25 oral cancer patients. Demographic data including data related to different risk factors, modified gingival index, oral hygiene level, in addition to salivary levels of IL-6, IL-8 and sCD44 were assessed.

Conditions

Oral Cancer

Outcome Measures

Primary Outcomes (2)

• Quantities of IL-6 and IL-8

  assessed in all samples using an ELISA kit (Orgenium laboratories, Business Unit, Finland). The test principles apply a sandwich-type ELISA where a polyclonal anti-antibody, adsorbed onto microwells, binds IL-6 and IL-8 in the samples, Results were expressed in pg/ml

  baseline

• Levels of sCD44

  measured using an ELISA assay (Bender MedSystems, Vienna, Austria) that identifies all normal and variant isoforms. Saliva samples were centrifuged at 2000 Xg and the supernatants were separated and stored at -80 ̊C till processing, which was done according to manufacturer's instructions. Results were expressed in ng/ml.

  Baselone

Secondary Outcomes (1)

• MGI (modified gingival index)

  baseline

Study Arms (4)

healthy controls

OTHER

healthy controls

Diagnostic Test: histologic evaluation; Diagnostic Test: biochemical analysis; Diagnostic Test: clinical examination

patients having OPMDs with dysplasia

OTHER

patients having OPMDs with dysplasia

Diagnostic Test: histologic evaluation; Diagnostic Test: biochemical analysis; Diagnostic Test: clinical examination

patients having OPMDs without dysplasia

OTHER

patients having OPMDs without dysplasia

Diagnostic Test: histologic evaluation; Diagnostic Test: biochemical analysis; Diagnostic Test: clinical examination

oral cancer patients

OTHER

oral cancer patients

Diagnostic Test: histologic evaluation; Diagnostic Test: biochemical analysis; Diagnostic Test: clinical examination

Interventions

histologic evaluation DIAGNOSTIC_TEST

histologic evaluation

healthy controls; oral cancer patients; patients having OPMDs with dysplasia; patients having OPMDs without dysplasia

biochemical analysis DIAGNOSTIC_TEST

IL-6, IL-8 and sCD44

healthy controls; oral cancer patients; patients having OPMDs with dysplasia; patients having OPMDs without dysplasia

clinical examination DIAGNOSTIC_TEST

clinical examination

healthy controls; oral cancer patients; patients having OPMDs with dysplasia; patients having OPMDs without dysplasia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients above 18 years both males and females patients presenting with OPMDs

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

British University in Egypt

Cairo, 112344, Egypt

Location

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 24, 2024
• Study Start: July 15, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 15, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

EG (1)