Oral CancerNCT06031337
Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study
An observational study of Oral Cancer and Oral Squamous Cell Carcinoma, run by Fayoum University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Oral Squamous Cell Carcinoma
- What is being tested?
- ELISA
- Type of treatment
- Pill or oral medicine
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Sep 2023to 1 Dec 2023
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 23 patients with oral cancer 23 healthy controls
Who may be able to join
- patients with oral cancer
Who cannot join
- any systemic diseases or other types of cancer will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Oral Cancer, Oral Squamous Cell Carcinoma
- Being tested
- ELISA
- Medical subject headings
- Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Cancer Group | 23 patients with oral cancer Receives: Diagnostic Test: ELISA | |
| Control Group | 23 age-and-sex-matched healthy individuals, as normal controls Receives: Diagnostic Test: ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary expression of SOX7
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start3 Sep 2023
- Primary completion22 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salsabeel, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031337
- Sponsor's protocol ID
- 1591985
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: on request
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT06031337
- Acronym / sponsor ID
- 1591985
- Conditions
- Oral Cancer, Oral Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Cancer Group | – | Diagnostic Test: ELISA23 patients with oral cancer |
| Control Group | – | Diagnostic Test: ELISA23 age-and-sex-matched healthy individuals, as normal controls |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 23 patients with oral cancer 23 healthy controls
Key inclusion criteria (1 listed)
- patients with oral cancer
Key exclusion criteria (1 listed)
- any systemic diseases or other types of cancer will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISAquantitative determination of salivary SOX7 using an Enzyme Linked Immunosorbent assay (ELISA) kit based on the sandwich principle according to the manufacturer's protocol. | Diagnostic test | Control Group, Oral Cancer Group |
Primary outcome
salivary expression of SOX7
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Undecided. on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer and Oral Squamous Cell Carcinoma, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary expression of SOX7 (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.