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

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.

Study Overview

• Status: Completed
• Conditions: Oral Cancer
• Intervention / Treatment: Diagnostic test: clinical examination; Diagnostic test: histologic evaluation; Diagnostic test: biochemical analysis

Detailed Description

Histopathologic evaluation:

Biopsy samples were obtained from all lesions to verify the diagnosis and establish the presence of dysplasia in the potentially premalignant lesions before allocating patients to their specific groups.

History and clinical assessment:

Demographic data as age and gender, medical history and habits as smoking and alcohol were obtained during patient interview. Modified gingival index (MGI), level of oral hygiene (OH) and the number of remaining natural teeth were also assessed. Subjects not willing to sign a written informed consent, pregnant females, lactating mothers, and patients with immunosuppressive disorders were excluded.

Modified gingival index (MGI) evaluates the presence and degree of gingival inflammation. A score of 0 means absence of inflammation. 1 indicates mild inflammation (slight redness) of any part of the gingiva. 2- mild inflammation of the whole gingiva. 3- moderate inflammation (moderate redness, edema, and/or hypertrophy) of the gingiva. 4-severe inflammation (marked redness and spontaneous bleeding) of the gingiva. Level of OH care was evaluated corresponding to the OH habits of the patient and efficiency of plaque removal. OH, level is scored as: 1- very good, 2- good, 3- fair, and 4- poor OH.

Collection of 1.0-2.0 mL of whole unstimulated saliva was obtained between nine and twelve in the morning, to evade diurnal alteration. Participants refrained from eating, smoking, brushing, and mouthwash use, 2 hours before to salivary sampling, which were stored at -70 ◦C till analyzed.

Quantification of salivary IL-6, IL-8, and sCD44 in all samples using an ELISA kit

List of abbreviations:

OSCC: Oral squamous cell carcinoma OPMDs: Oral potentially malignant disorders HNSCC: Head and neck squamous cell carcinoma MGI: Modified gingival index. OH: Level of oral hygiene ROC: Receiver operating characteristic

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 112344
    • British University In Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: healthy controls	Diagnostic test: clinical examination; clinical examination; Diagnostic test: histologic evaluation; histologic evaluation; Diagnostic test: biochemical analysis; IL-6, IL-8 and sCD44
Other: patients having OPMDs with dysplasia	Diagnostic test: clinical examination; clinical examination; Diagnostic test: histologic evaluation; histologic evaluation; Diagnostic test: biochemical analysis; IL-6, IL-8 and sCD44
Other: patients having OPMDs without dysplasia	Diagnostic test: clinical examination; clinical examination; Diagnostic test: histologic evaluation; histologic evaluation; Diagnostic test: biochemical analysis; IL-6, IL-8 and sCD44
Other: oral cancer patients	Diagnostic test: clinical examination; clinical examination; Diagnostic test: histologic evaluation; histologic evaluation; Diagnostic test: biochemical analysis; IL-6, IL-8 and sCD44

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MGI (modified gingival index)	Modified gingival index (MGI) evaluates the presence and degree of gingival inflammation. A score of 0 means absence of inflammation. 1 indicates mild inflammation (slight redness) of any part of the gingiva. 2- mild inflammation of the whole gingiva. 3- moderate inflammation (moderate redness, edema, and/or hypertrophy) of the gingiva. 4-severe inflammation (marked redness and spontaneous bleeding) of the gingiva.	baseline

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Neoplasms; Lip Neoplasms
• Other Study ID Numbers: BU1612

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No