Oral Lichen PlanusNCT04267419
Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions
An observational study of Oral Lichen Planus and Oral Cancer, run by Beni-Suef University at 1 site in Egypt.
Trial summary
investigating the level of malondialdehyde (MDA) \& nitric oxide (NO) in saliva in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant and potentially malignant lesions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Oral Lichen Planus, Oral Cancer, Leukoplakia
- What is being tested?
- salivary biomarker
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2019to 15 Dec 2019
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: out patients
Who may be able to join
- healthy individuals with one of the following oral lesions :
- keratosis
- Oral lichen planus
- oral squamous cell carcinoma
- oral leukoplakia
Who cannot join
- subjects having systemic disorders
- pregnant or lactating females;
- subjects who suffered from any other mucosal lesions;
- severe periodontal inflammation.
Trial locations and contacts
1 site in 1 country.
About this study
investigating the level of malondialdehyde (MDA) \& nitric oxide (NO) in saliva in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant and potentially malignant lesions.
Read the detailed description
Being a detrimental disease, cancer development is a very complicated process that requires many sequential steps and depends on a various number of genetic alterations and factors(1). Among these factors are the free radicals which are derived either from endogenous or exogenous sources (5). Free radicals result in an oxidative stress of the affected cells generating a body imbalance between oxidants and antioxidants (6).
In this regard, saliva has been currently used to assess this possible oxidative imbalance through various salivary biomarkers including nitric oxide (NO) and malondialdehyde (MDA). Saliva could be used as a very interesting rich medium, known for its role in diagnosis, prognosis and treatment that has become more prominent in oral diseases (6).
Nitric oxide (NO) is an intercellular messenger molecule having many important biological functions. The levels of nitric oxide in salivary secretions could be used to monitor the severity of many underlying disease processes. Moreover, malondialdehyde (MDA) has been the most frequently used biomarker of oxidative stress in many pathological conditions such as cancer. It resulted from reactive oxygen species lipid degradation and induced toxic stress in affected cells, making both biomarkers a point of focus in monitoring clinical progress of suspected lesions
- Conditions
- Oral Lichen Planus, Oral Cancer, Leukoplakia, Oral Keratoses
- Being tested
- salivary biomarker
- Keywords
- malondialdehyde, nitric oxide, salivary biomarkers
- Medical subject headings
- Lichen Planus, Oral, Mouth Neoplasms, Leukoplakia, Leukoplakia, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salivary biomarkerDiagnostic test
MDA and NO as salivary biomarkers
| Study group | Role | What they receive |
|---|---|---|
| healthy Control | MDA and NO in saliva Receives: Diagnostic Test: salivary biomarker | |
| keratosis | MDA and NO in saliva Receives: Diagnostic Test: salivary biomarker | |
| leukoplakia | MDA and NO in saliva Receives: Diagnostic Test: salivary biomarker | |
| Oral lichen Planus | MDA and NO in saliva Receives: Diagnostic Test: salivary biomarker | |
| oral Squamous cell carcinoma | MDA and NO in saliva Receives: Diagnostic Test: salivary biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary MDA level in different oral lesions
The MDA level in saliva measured using ELISA kit provided by My BioSource, USA.
Measured: 9 months
Salivary NO level in different oral lesions
The nitric oxide level in saliva measured using ELISA kit provided by My BioSource, USA.
Measured: 9 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start18 Feb 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Abdelkawy, Phd, Beni-Suef University
- Investigators
- weam Elbattawy, Phd, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267419
- Sponsor's protocol ID
- FDBSUREC/17022019/AM
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2020
- Last updated
- 13 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all the data will shared once the work is published
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malondialdehyde and Nitrous Oxide as Salivary Biomarkers for Different Oral Lesions
- ClinicalTrials.gov ID
- NCT04267419
- Acronym / sponsor ID
- FDBSUREC/17022019/AM
- Conditions
- Oral Lichen Planus, Oral Cancer, Leukoplakia, Oral Keratoses
- Keywords
- malondialdehyde, nitric oxide, salivary biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 12 Feb 2020 (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.
investigating the level of malondialdehyde (MDA) \& nitric oxide (NO) in saliva in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant and potentially malignant lesions.
Detailed description
Being a detrimental disease, cancer development is a very complicated process that requires many sequential steps and depends on a various number of genetic alterations and factors(1). Among these factors are the free radicals which are derived either from endogenous or exogenous sources (5). Free radicals result in an oxidative stress of the affected cells generating a body imbalance between oxidants and antioxidants (6).
In this regard, saliva has been currently used to assess this possible oxidative imbalance through various salivary biomarkers including nitric oxide (NO) and malondialdehyde (MDA). Saliva could be used as a very interesting rich medium, known for its role in diagnosis, prognosis and treatment that has become more prominent in oral diseases (6).
Nitric oxide (NO) is an intercellular messenger molecule having many important biological functions. The levels of nitric oxide in salivary secretions could be used to monitor the severity of many underlying disease processes. Moreover, malondialdehyde (MDA) has been the most frequently used biomarker of oxidative stress in many pathological conditions such as cancer. It resulted from reactive oxygen species lipid degradation and induced toxic stress in affected cells, making both biomarkers a point of focus in monitoring clinical progress of suspected lesions
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| healthy Control | – | Diagnostic Test: salivary biomarkerMDA and NO in saliva |
| keratosis | – | Diagnostic Test: salivary biomarkerMDA and NO in saliva |
| leukoplakia | – | Diagnostic Test: salivary biomarkerMDA and NO in saliva |
| Oral lichen Planus | – | Diagnostic Test: salivary biomarkerMDA and NO in saliva |
| oral Squamous cell carcinoma | – | Diagnostic Test: salivary biomarkerMDA and NO in saliva |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- out patients
Key inclusion criteria (5 listed)
- healthy individuals with one of the following oral lesions :
Key exclusion criteria (4 listed)
- subjects having systemic disorders
- pregnant or lactating females;
- subjects who suffered from any other mucosal lesions;
- severe periodontal inflammation.
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 |
|---|---|---|
| salivary biomarkerMDA and NO as salivary biomarkers | Diagnostic test | Oral lichen Planus, healthy Control, keratosis, leukoplakia, oral Squamous cell carcinoma |
Primary outcome
Salivary MDA level in different oral lesions
Time frame: 9 months
The MDA level in saliva measured using ELISA kit provided by My BioSource, USA.
Salivary NO level in different oral lesions
Time frame: 9 MONTHS
The nitric oxide level in saliva measured using ELISA kit provided by My BioSource, USA.
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 13 Feb 2020.
- Individual participant dataSharing planned: Yes. all the data will shared once the work is published
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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.
weam Elbattawy, Phd 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 Oral Lichen Planus and Oral Cancer, run by Beni-Suef 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 5 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 13 Feb 2020. 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 MDA level in different oral lesions (time frame: 9 months). The study lists 2 primary outcomes in all. 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 13 Feb 2020.