The Long Non Coding MALAT1 as a Potential Salivary Diagnostic Biomarker in Oral Squamous Cell Carcinoma Through Targeting mi RNA 124

• Sponsor: Fayoum University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05708209
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Actual Duration (Months): 2
• Patients Per Site Per Month: 20

Study Details

Study Description

Brief Summary

Objective: is to determine the diagnostic accuracy of lncRNA MALAT1 as a potential salivary biomarker of OSCC as well as assessment of the salivary expression level of miRNA 124 which is targeted by MALAT1. Materials and Methods: Saliva Samples were collected for the quantitative determination of salivary "MALAT1 and mi RNA -124" using quantitative Real-time Polymerase Chain Reaction technique for the two study groups, Group A: 20 patients with a diagnosis suggestive of OSCC and Group B: 20 age-and-sex-matched healthy individuals, as normal controls.

Condition or Disease	Intervention/Treatment	Phase
Oral Cancer Biomarkers

Detailed Description

Materials and Methods: Saliva Samples were collected for the quantitative determination of salivary "MALAT1 and mi RNA -124" using quantitative Real-time Polymerase Chain Reaction technique for the two study groups, Group A: 20 patients with a diagnosis suggestive of OSCC and Group B: 20 age-and-sex-matched healthy individuals, as normal controls.

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: The Long Non Coding MALAT1 as a Potential Salivary Diagnostic Biomarker in Oral Squamous Cell Carcinoma Through Targeting mi RNA 124
• Actual Study Start Date: Nov 1, 2022
• Actual Primary Completion Date: Dec 1, 2022
• Actual Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group A 20 patients with a diagnosis suggestive of OSCC
Group B 20 age-and-sex-matched healthy individuals, as normal controls.

Outcome Measures

Primary Outcome Measures

1. quantitative determination of salivary non-coding RNAs "MALAT1 [2 months]

   quantitative determination of salivary non-coding RNAs "MALAT1 using quantitative Real-time Polymerase Chain Reaction technique (qRT-PCR) in the whole unstimulated saliva

Secondary Outcome Measures

1. quantitative determination of salivary mi RNA -124" [2 months]

   quantitative determination of salivary mi RNA -124" using quantitative Real-time Polymerase Chain Reaction technique (qRT-PCR) in the whole unstimulated saliva

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• The study included patients with OSCC and healthy controls of both sexes.

Exclusion Criteria:

• Patients having systemic diseases such as; liver diseases, cardiovascular disease, nervous system, pulmonary, renal, endocrine, gastrointestinal disorders, or other types of cancer were excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rania Hassan Shalby	Giza		Egypt

Sponsors and Collaborators

• Fayoum University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rania Hassan Shalby, Lecturer of Oral Medicine, Fayoum University
• ClinicalTrials.gov Identifier: NCT05708209
• Other Study ID Numbers: 19038219038211012
• First Posted: Feb 1, 2023
• Last Update Posted: Feb 1, 2023
• Last Verified: Jan 1, 2023

• Keywords provided by Rania Hassan Shalby, Lecturer of Oral Medicine, Fayoum University: Long non coding RNA, Oral squamous cell carcinoma, Micro RNA, Salivary biomarkers, MALAT1, Oral cancer biomarkers
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Feb 1, 2023