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

September 10, 2023 updated by: Rania Hassan Shalby, Fayoum University
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Rania Hassan Shalby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of oral squamous cell carcinoma

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantitative determination of salivary non-coding RNAs "MALAT1
Time Frame: 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
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantitative determination of salivary mi RNA -124"
Time Frame: 2 months
quantitative determination of salivary mi RNA -124" using quantitative Real-time Polymerase Chain Reaction technique (qRT-PCR) in the whole unstimulated saliva
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

January 22, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 10, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19038219038211012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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