NCT05708209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

January 22, 2023

Last Update Submit

September 10, 2023

Conditions

Oral Squamous Cell Carcinoma

Keywords

Long non coding RNA, Oral squamous cell carcinoma, Micro RNA, Salivary biomarkers, MALAT1, Oral cancer biomarkers

Outcome Measures

Primary Outcomes (1)

  • quantitative determination of salivary non-coding RNAs "MALAT1

    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 Outcomes (1)

  • quantitative determination of salivary mi RNA -124"

    2 months

Study Arms (2)

Group A

20 patients with a diagnosis suggestive of OSCC

Group B

20 age-and-sex-matched healthy individuals, as normal controls.

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of oral squamous cell carcinoma

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rania Hassan Shalby

Giza, Egypt

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Oral Medicine

Study Record Dates

First Submitted

January 22, 2023

First Posted

February 1, 2023

Study Start

November 1, 2022

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

EG(1)