NCT06031337

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

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

First Submitted

Initial submission to the registry

September 2, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

September 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 2, 2023

Last Update Submit

September 25, 2024

Conditions

Oral CancerOral Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • salivary expression of SOX7

    2 months

Study Arms (2)

Oral Cancer Group

23 patients with oral cancer

Diagnostic Test: ELISA

Control Group

23 age-and-sex-matched healthy individuals, as normal controls

Diagnostic Test: ELISA

Interventions

ELISADIAGNOSTIC_TEST

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 GroupOral Cancer Group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

23 patients with oral cancer 23 healthy controls

You may qualify if:

  • patients with oral cancer

You may not qualify if:

  • any systemic diseases or other types of cancer will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Mouth NeoplasmsSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 2, 2023

First Posted

September 11, 2023

Study Start

September 3, 2023

Primary Completion

November 22, 2023

Study Completion

December 1, 2023

Last Updated

September 27, 2024

Record last verified: 2024-09

Locations

EG(1)