Comparison of Salivary Paxillin Levels in OPMLs and OSCC to Healthy SubjectsNCT06154551
Evaluation of the Levels of Salivary Paxillin Oral Premalignant and Malignant Lesions
An observational study of Comparison of Salivary Paxillin Levels in OPMLs and OSCC to Healthy Subjects, run by Cairo University at 1 site in Egypt.
Trial summary
This investigation was carried out to analyze and compare the salivary paxillin levels between oral premalignant and malignant lesions (OPMLs), OSCC and the healthy controls in order to assess its potential role as a biomarker of oral cancer aiming for early diagnosis and better prognosis of OSCC. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Comparison of Salivary Paxillin Levels in OPMLs and OSCC to Healthy Subjects
- What is being tested?
- Paxillin biomarker
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Nov 2022to 1 Nov 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Forty-five participants between the ages of 30 and 70 were accepted for this study. They were registered in the outpatient's clinic of Oral Medicine and Periodontology department in Faculty of Dentistry,Cairo university. Three sets of subjects were assigned: fifteen patients with premalignant lesions, fifteen patients with OSCC, and fifteen systemically healthy control subjects
Who may be able to join
- patients with leukoplakia patients with atropic lichen planus patients with bullous erosive lichen planus patients with squamous cell carcinoma
Who cannot join
- patients with papular lichen planus patients with underlying systemic disease leukemic patients smokers hepatic patients
Trial locations and contacts
1 site in 1 country.
About this study
This investigation was carried out to analyze and compare the salivary paxillin levels between oral premalignant and malignant lesions (OPMLs), OSCC and the healthy controls in order to assess its potential role as a biomarker of oral cancer aiming for early diagnosis and better prognosis of OSCC.
Methods: Forty-five patients, ranging in age from thirty to seventy-five, were divided into three groups: fifteen patients with OPMLs (lichen planus, leukoplakia), fifteen patients with OSCC, and fifteen controls who were in general well. Paxillin was identified in saliva samples by using an ELISA kit.
Read the detailed description
The aim of this study is: comparison of salivary paxillin levels in oral premalignant lesions and OSCC to its levels in healthy subjects.
Subjects and Methods Forty-five participants between the ages of 30 and 70 were accepted for this study. They were registered in the outpatient's clinic of Oral Medicine and Periodontology department in Faculty of Dentistry,Cairo university. Three sets of subjects were assigned: fifteen patients with premalignant lesions, fifteen patients with OSCC, and fifteen systemically healthy control subjects. A complete medical history was obtained for each individual using a modified Cornell Medical Index questionnaire. Upon receiving clarification regarding the scope of the inquiry, each participant completed an informed consent form.
Patients with OSCC were clinically diagnosed, and biopsy specimens from the lesions were taken for histology to confirm the diagnosis.
Collection of saliva samples:
Unstimulated Salivary samples were collected once preoperatively before any intervention All participants were asked to refrain from drinking, eating, or chewing gum for at least 60 minutes before sampling. Samples were collected by asking the patient to swallow first, then lean the head forward for 5 minutes and spit the entire saliva into 50-ml sterile centrifuge tubes. After being assembled, all specimens were immediately stored at -20 ºC until tested.
Quantitation of Human Paxillin salivary level:
Saliva was collected from patients and controls. After centrifugation, the supernatant was separated for detection of Paxillin by using the ELISA technique provided by Cloud Clone Corp, Houston, USA, Catalogue Number: E-01184hu. This kit's microtiter plate has been pre-coated with a paxillin-specific antibody. The relevant microtiter plate wells are then treated with a biotin-conjugated antibody specific to paxillin. Then, Avidin conjugated to Horseradish Peroxidase (HRP) is added and incubated in each microplate well. After adding the TMB substrate solution, only the wells containing paxillin, biotin-conjugated antibody, and enzyme-conjugated Avidin will change colour. The enzyme-substrate reaction is stopped by adding a solution of sulphuric acid, and the colour change is measured spectrophotometrically at 450nm 10nm. The samples' optical density (OD) is then compared to the reference curve to determine their paxillin concentration.
Statistical analysis:
Categorical data were given as frequency and percentage values, and Fisher's exact test was used to assess them. Mean and standard deviation (SD) numbers were used to depict numerical data. The Shapiro-Wilk test was used to determine their normalcy. A one-way ANOVA test followed by Tukey's post hoc test was used to analyse normally distributed data (age and Paxillin (ng/mL) levels). ROC curve analysis was done to determine diagnostic accuracy. A z-test was used to compare ROC curves. The significance level was set at p<0.05 for all tests. R statistical analysis software version 4.3.1 for Windows was used for the statistical analysis [18].
- Being tested
- Paxillin biomarker
- Keywords
- oral potentially malignant lesions, oral squamous cell carcinoma, saliva, paxillin
- Medical subject headings
- 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.
Paxillin biomarkerDiagnostic test
Paxillin used as a salivary biomarker
| Study group | Role | What they receive |
|---|---|---|
| Group A | fifteen patients with OPMLs (lichen planus, leukoplakia) Receives: Diagnostic Test: Paxillin biomarker | |
| Group B | fifteen patients with OSCC Receives: Diagnostic Test: Paxillin biomarker | |
| Group C | fifteen systemically healthy control subjects Receives: Diagnostic Test: Paxillin biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary levels of paxillin
to detect the levels of salivary paxillin and compare its levels in the three study groups
Measured: once preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start29 Nov 2022
- Primary completion20 Jun 2023
- Study completion1 Nov 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 Comparison of Salivary Paxillin Levels in OPMLs and OSCC to Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Olfat Shaker
- Responsible party
- Principal investigator, Yasmine Kamal, Cairo University
- Investigators
- Yasmine Ramadan, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154551
- Sponsor's protocol ID
- 321122
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hussine AA, Selim K, Shaker O, Kamal Y. Evaluation of the levels of salivary paxillin in oral potentially malignant disorders and malignant lesions. BMC Oral Health. 2024 Jul 24;24(1):834. doi: 10.1186/s12903-024-04569-z.
PubMed 39048985
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Levels of Salivary Paxillin Oral Premalignant and Malignant Lesions
- ClinicalTrials.gov ID
- NCT06154551
- Acronym / sponsor ID
- 321122
- Keywords
- oral potentially malignant lesions, oral squamous cell carcinoma, saliva, paxillin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Olfat Shaker
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 4 Dec 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.
This investigation was carried out to analyze and compare the salivary paxillin levels between oral premalignant and malignant lesions (OPMLs), OSCC and the healthy controls in order to assess its potential role as a biomarker of oral cancer aiming for early diagnosis and better prognosis of OSCC.
Methods: Forty-five patients, ranging in age from thirty to seventy-five, were divided into three groups: fifteen patients with OPMLs (lichen planus, leukoplakia), fifteen patients with OSCC, and fifteen controls who were in general well. Paxillin was identified in saliva samples by using an ELISA kit.
Detailed description
The aim of this study is: comparison of salivary paxillin levels in oral premalignant lesions and OSCC to its levels in healthy subjects.
Subjects and Methods Forty-five participants between the ages of 30 and 70 were accepted for this study. They were registered in the outpatient's clinic of Oral Medicine and Periodontology department in Faculty of Dentistry,Cairo university. Three sets of subjects were assigned: fifteen patients with premalignant lesions, fifteen patients with OSCC, and fifteen systemically healthy control subjects. A complete medical history was obtained for each individual using a modified Cornell Medical Index questionnaire. Upon receiving clarification regarding the scope of the inquiry, each participant completed an informed consent form.
Patients with OSCC were clinically diagnosed, and biopsy specimens from the lesions were taken for histology to confirm the diagnosis.
Collection of saliva samples:
Unstimulated Salivary samples were collected once preoperatively before any intervention All participants were asked to refrain from drinking, eating, or chewing gum for at least 60 minutes before sampling. Samples were collected by asking the patient to swallow first, then lean the head forward for 5 minutes and spit the entire saliva into 50-ml sterile centrifuge tubes. After being assembled, all specimens were immediately stored at -20 ºC until tested.
Quantitation of Human Paxillin salivary level:
Saliva was collected from patients and controls. After centrifugation, the supernatant was separated for detection of Paxillin by using the ELISA technique provided by Cloud Clone Corp, Houston, USA, Catalogue Number: E-01184hu. This kit's microtiter plate has been pre-coated with a paxillin-specific antibody. The relevant microtiter plate wells are then treated with a biotin-conjugated antibody specific to paxillin. Then, Avidin conjugated to Horseradish Peroxidase (HRP) is added and incubated in each microplate well. After adding the TMB substrate solution, only the wells containing paxillin, biotin-conjugated antibody, and enzyme-conjugated Avidin will change colour. The enzyme-substrate reaction is stopped by adding a solution of sulphuric acid, and the colour change is measured spectrophotometrically at 450nm 10nm. The samples' optical density (OD) is then compared to the reference curve to determine their paxillin concentration.
Statistical analysis:
Categorical data were given as frequency and percentage values, and Fisher's exact test was used to assess them. Mean and standard deviation (SD) numbers were used to depict numerical data. The Shapiro-Wilk test was used to determine their normalcy. A one-way ANOVA test followed by Tukey's post hoc test was used to analyse normally distributed data (age and Paxillin (ng/mL) levels). ROC curve analysis was done to determine diagnostic accuracy. A z-test was used to compare ROC curves. The significance level was set at p<0.05 for all tests. R statistical analysis software version 4.3.1 for Windows was used for the statistical analysis [18].
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: Paxillin biomarkerfifteen patients with OPMLs (lichen planus, leukoplakia) |
| Group B | – | Diagnostic Test: Paxillin biomarkerfifteen patients with OSCC |
| Group C | – | Diagnostic Test: Paxillin biomarkerfifteen systemically healthy control subjects |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Forty-five participants between the ages of 30 and 70 were accepted for this study. They were registered in the outpatient's clinic of Oral Medicine and Periodontology department in Faculty of Dentistry,Cairo university. Three sets of subjects were assigned: fifteen patients with premalignant lesions, fifteen patients with OSCC, and fifteen systemically healthy control subjects
Key inclusion criteria (1 listed)
- patients with leukoplakia patients with atropic lichen planus patients with bullous erosive lichen planus patients with squamous cell carcinoma
Key exclusion criteria (1 listed)
- patients with papular lichen planus patients with underlying systemic disease leukemic patients smokers hepatic patients
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 |
|---|---|---|
| Paxillin biomarkerPaxillin used as a salivary biomarker | Diagnostic test | Group A, Group B, Group C |
Primary outcome
salivary levels of paxillin
Time frame: once preoperatively
to detect the levels of salivary paxillin and compare its levels in the three study groups
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 4 Dec 2023.
- Derived from this study: PubMed 39048985Hussine AA, Selim K, Shaker O, Kamal Y. Evaluation of the levels of salivary paxillin in oral potentially malignant disorders and malignant lesions. BMC Oral Health. 2024 Jul 24;24(1):834. doi: 10.1186/s12903-024-04569-z.
- Individual participant dataSharing planned: Undecided
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.
Yasmine Ramadan principal investigator
Cairo 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 Comparison of Salivary Paxillin Levels in OPMLs and OSCC to Healthy Subjects, run by Cairo 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 4 Dec 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?
salivary levels of paxillin (time frame: once preoperatively). 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 NCT06154551, 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 4 Dec 2023.