Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study

September 25, 2024 updated by: Salsabeel, Fayoum University
The study will include patients with oral cancer and healthy controls of both sexes. Subjects having any systemic diseases or other types of cancer will be excluded. All subjects will be selected from Oral Medicine Department, Faculty of Dentistry, Al Ahram Canadian University and Fayoum University. Informed consent will be obtained from all subjects enrolled in this study after explanation of the whole procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

46

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
      • Fayoum, Egypt
        • Fayoum University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

23 patients with oral cancer 23 healthy controls

Description

Inclusion Criteria:

  • patients with oral cancer

Exclusion Criteria:

  • any systemic diseases or other types of cancer will be 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
Intervention / Treatment
Oral Cancer Group
23 patients with oral cancer
Diagnostic test: ELISA
quantitative determination of salivary SOX7 using an Enzyme Linked Immunosorbent assay (ELISA) kit based on the sandwich principle according to the manufacturer's protocol.
Control Group
23 age-and-sex-matched healthy individuals, as normal controls
Diagnostic test: ELISA
quantitative determination of salivary SOX7 using an Enzyme Linked Immunosorbent assay (ELISA) kit based on the sandwich principle according to the manufacturer's protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
salivary expression of SOX7
Time Frame: 2 months
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)

September 3, 2023

Primary Completion (Actual)

November 22, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

September 2, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1591985

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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