Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma

NCT05821179 | Completed

• 1 other identifier: M1
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included.

Conditions

Oral Squamous Cell Carcinoma

Keywords

Oral squamous cell carcinoma, oral potentially malignant disorders, saliva, LINC00657, miR-106a.

Outcome Measures

Primary Outcomes (1)

• LINC00657 level in salivary samples from all participants measured using PCR

  quantitative real-time PCR is used to detect LINC00657 levels in saliva samples from patients with OSCC and OPMD compared to healthy subjects

  level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation after diagnosis confirmation

Secondary Outcomes (1)

• miR-106a level in salivary samples from the included subjects evaluated by PCR

  level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation

Study Arms (3)

Group I

12 patients diagnosed with OSCC.

Group II

12 patients diagnosed with OLP.

Group III

12 systemically free individuals with no oral mucosal lesions.

Eligibility Criteria

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

Study Population

\- patients recruited from the outpatient clinic of departments of oral diagnosis and medicine and periodontology Fayoum, Beni-Suef and Ahram-Candian universities

You may qualify if:

• group I : oral squamous cell carcinoma lesions (OSCC)
• group II: oral lichen planus lesions (OLP)
• group III: systemically healthy volunteers

You may not qualify if:

• oral lesions other than OSCC / OLP in group I and II
• any oral lesion in group III
• pregnant females

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

faculty of dentistry, Fayoum university

Al Fayyum, Egypt

Location

Related Publications (1)

• Tarrad NAF, Hassan S, Shaker OG, AbdelKawy M. "Salivary LINC00657 and miRNA-106a as diagnostic biomarkers for oral squamous cell carcinoma, an observational diagnostic study". BMC Oral Health. 2023 Dec 12;23(1):994. doi: 10.1186/s12903-023-03726-0.

  PMID: 38087258 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Nayroz Tarrad, as. professor

  faculty of dentistry, Fayoum university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 20, 2023
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 25, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)