Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions
NCT ID: NCT06087042
Last Updated: 2023-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
45 participants
OBSERVATIONAL
2023-08-15
2023-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validation of Salivary Proteomic Biomarkers for Early Detection of Oral Cancer in Egyptian Population
NCT06471270
8-Hydroxy-2-Deoxyguanosine ,Total Antioxidant Capacity in Oral Premalignant and Malignant Lesions
NCT03830710
Diagnostic Accuracy of Mobile Phone Imaging Compared to Conventional Clinical Examination for Oral Cancer Screening
NCT06060288
Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion
NCT02581137
Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study
NCT06031337
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group I
patients suffering from oral squamous cell carcinoma
serum and unstimulated salivary samples
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
Group II
patients diagnosed with potentially malignant lesions such as leukoplakia, and dysplastic erosive or atrophic oral lichen planus
serum and unstimulated salivary samples
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
Group III
individuals with no oral mucosal lesions
serum and unstimulated salivary samples
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
serum and unstimulated salivary samples
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* pregnancy
* lactation
* being diagnosed with any other oral mucosal lesion
30 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fayoum University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nayroz Tarrad
associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nayroz Tarrad, associate professor
Role: PRINCIPAL_INVESTIGATOR
faculty of dentistry, Fayoum university
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
faculty of dentistry, Fayoum university
Al Fayyum, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
: IRB00012891#77
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.