Oral Premalignant Lesions as Leukoplakia and Lichen PlanusNCT06087042
Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions
An observational study of Oral Premalignant Lesions as Leukoplakia and Lichen Planus and Oral Cancer, run by Fayoum University at 1 site in Egypt.
Trial summary
Aim: The current study targets linking serum and salivary dipeptidyl peptidase-4 with oral squamous cell carcinoma and comparing it with potentially malignant lesions and control to validate dipeptidyl peptidase-4 as a diagnostic marker for early detection of oral cancer and to reveal its possible role in… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Premalignant Lesions as Leukoplakia and Lichen Planus, Oral Cancer
- What is being tested?
- serum and unstimulated salivary samples
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2023to 1 Oct 2023
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult individuals entering in the out patient clinics of oral medicine and diagnosis department
Who may be able to join
- systemically healthy
- No current medication,
- both genders with age ranging from 30 to 65 years old.
- having oral leukoplakia, oral lichen planus or oral squamous cell carcinoma
Who cannot join
- systemic disease
- pregnancy
- lactation
- being diagnosed with any other oral mucosal lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Serum and Salivary Dipeptidyl Peptidase-4 (DPP-4) With Oral Cancerous and Precancerous Lesions; an Observational Diagnostic Accuracy Study
Aim: The current study targets linking serum and salivary dipeptidyl peptidase-4 with oral squamous cell carcinoma and comparing it with potentially malignant lesions and control to validate dipeptidyl peptidase-4 as a diagnostic marker for early detection of oral cancer and to reveal its possible role in carcinogenesis.
Methodology: A total of 45 patients were recruited and subdivided into 2 groups: Group I: 15 patients having oral squamous cell carcinoma. Group II: 15 patients with potentially malignant lesions (leukoplakia and oral lichen planus) compared to 15 systemically healthy participants having no oral mucosal lesions acting as a control group (Group III). Serum and whole unstimulated salivary samples were collected from all participants to evaluate dipeptidyl peptidase level in different groups using enzyme linked immune-sorbent assay (ELISA) kit. ROC analysis was done to reveal area under the curve, sensitivity, specificity and diagnostic accuracy of DPP-4 among different groups.
- Being tested
- serum and unstimulated salivary samples
- Keywords
- oral cancer, saliva, serum, dipeptidyl peptidase, potentially malignant lesions.
- Medical subject headings
- Lichen Planus, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum and unstimulated salivary samplesDiagnostic test
Participants were told to cease smoking, eating, or drinking before the collection of samples by about half an hour. Obtaining the sample was done by demanding the individual to swallow then incline his head forward to expectorate saliva in a sterile tube for about 3 min. Afterwards the samples were coded by serial numbers then stored at -20°C until being assessed.
Under aseptic circumstances and using plain tubes, 5ml peripheral venous blood samples were collected from all participants by standard venipuncture. Samples were transported to biochemistry laboratory and centrifuged followed by filtration of the clarifying supernatant and then stored at -20ºC
| Study group | Role | What they receive |
|---|---|---|
| Group I | patients suffering from oral squamous cell carcinoma Receives: Diagnostic Test: serum and unstimulated salivary samples | |
| Group II | patients diagnosed with potentially malignant lesions such as leukoplakia, and dysplastic erosive or atrophic oral lichen planus Receives: Diagnostic Test: serum and unstimulated salivary samples | |
| Group III | individuals with no oral mucosal lesions Receives: Diagnostic Test: serum and unstimulated salivary samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
DPP-4 level detection
level of DPP-4 is measured in all collected serum and salivary samples
Measured: level of DPP-4 is measured after the completion of all sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start15 Aug 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Premalignant Lesions as Leukoplakia and Lichen PlanusStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayroz Tarrad, Fayoum University
- Investigators
- Nayroz Tarrad, associate professor, Principal investigator, faculty of dentistry, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087042
- Sponsor's protocol ID
- : IRB00012891#77
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdel Fattah Tarrad N, Gamil Shaker O, Abdelkawy M, Hassan S. Association of serum and salivary dipeptidyl peptidase-4 (DPP-4) with oral cancerous and precancerous lesions; an observational diagnostic accuracy study. BMC Oral Health. 2024 Oct 10;24(1):1206. doi: 10.1186/s12903-024-04939-7.
PubMed 39390508
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Serum and Salivary Dipeptidyl Peptidase-4 (DPP-4) With Oral Cancerous and Precancerous Lesions; an Observational Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT06087042
- Acronym / sponsor ID
- : IRB00012891#77
- Keywords
- oral cancer, saliva, serum, dipeptidyl peptidase, potentially malignant lesions.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 17 Oct 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.
Aim: The current study targets linking serum and salivary dipeptidyl peptidase-4 with oral squamous cell carcinoma and comparing it with potentially malignant lesions and control to validate dipeptidyl peptidase-4 as a diagnostic marker for early detection of oral cancer and to reveal its possible role in carcinogenesis.
Methodology: A total of 45 patients were recruited and subdivided into 2 groups: Group I: 15 patients having oral squamous cell carcinoma. Group II: 15 patients with potentially malignant lesions (leukoplakia and oral lichen planus) compared to 15 systemically healthy participants having no oral mucosal lesions acting as a control group (Group III). Serum and whole unstimulated salivary samples were collected from all participants to evaluate dipeptidyl peptidase level in different groups using enzyme linked immune-sorbent assay (ELISA) kit. ROC analysis was done to reveal area under the curve, sensitivity, specificity and diagnostic accuracy of DPP-4 among different groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: serum and unstimulated salivary samplespatients suffering from oral squamous cell carcinoma |
| Group II | – | Diagnostic Test: serum and unstimulated salivary samplespatients diagnosed with potentially malignant lesions such as leukoplakia, and dysplastic erosive or atrophic oral lichen planus |
| Group III | – | Diagnostic Test: serum and unstimulated salivary samplesindividuals with no oral mucosal lesions |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult individuals entering in the out patient clinics of oral medicine and diagnosis department
Key inclusion criteria (4 listed)
- systemically healthy
- No current medication,
- both genders with age ranging from 30 to 65 years old.
- having oral leukoplakia, oral lichen planus or oral squamous cell carcinoma
Key exclusion criteria (4 listed)
- systemic disease
- pregnancy
- lactation
- being diagnosed with any other oral mucosal lesion
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 |
|---|---|---|
| serum and unstimulated salivary samplesParticipants were told to cease smoking, eating, or drinking before the collection of samples by about half an hour. Obtaining the sample was done by demanding the individual to swallow then incline his head forward to expectorate saliva in a sterile tube for about 3 min. Afterwards the samples were coded by serial numbers then stored at -20°C until being assessed. Under aseptic circumstances and using plain tubes, 5ml peripheral venous blood samples were collected from all participants by standard venipuncture. Samples were transported to biochemistry laboratory and centrifuged followed by filtration of the clarifying supernatant and then stored at -20ºC | Diagnostic test | Group I, Group II, Group III |
Primary outcome
DPP-4 level detection
Time frame: level of DPP-4 is measured after the completion of all sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation
level of DPP-4 is measured in all collected serum and salivary samples
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 17 Oct 2023.
- Derived from this study: PubMed 39390508Abdel Fattah Tarrad N, Gamil Shaker O, Abdelkawy M, Hassan S. Association of serum and salivary dipeptidyl peptidase-4 (DPP-4) with oral cancerous and precancerous lesions; an observational diagnostic accuracy study. BMC Oral Health. 2024 Oct 10;24(1):1206. doi: 10.1186/s12903-024-04939-7.
- Individual participant dataSharing planned: No
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.
Nayroz Tarrad, associate professor principal investigator
faculty of dentistry, Fayoum university
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 Premalignant Lesions as Leukoplakia and Lichen Planus and Oral Cancer, 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 4 inclusion and 4 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 17 Oct 2023. 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?
DPP-4 level detection (time frame: level of DPP-4 is measured after the completion of all sample collection carried at the day of enrollment of subjects in the investigation after diagnosis confirmation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087042, which also lists 1 linked publication.
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 17 Oct 2023.