Premalignant LesionNCT03830710
8-Hydroxy-2-Deoxyguanosine ,Total Antioxidant Capacity in Oral Premalignant and Malignant Lesions
An observational study of Premalignant Lesion, run by Fayoum University at 1 site in Egypt.
Trial summary
Objectives: Investigating the level of salivary 8-hydroxy-2-deoxyguanosine (8-OHdG) and total antioxidant capacity (TAC) in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant patients. Read more about this study
- Who is it for?
- Ages 35 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Premalignant Lesion
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Dec 2018
- 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 35 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The included subjects were all assessed medically according to the modified Cornell Medical index (Kerr \& Millard, 1965).
Who may be able to join
- All included individuals were not under any current medication, suffering from any systemic condition or having any other oral mucosal disorder.
Who cannot join
- Pregnant or lactating females
- subjects having systemic disorder or taking medications;
- subjects who suffer from any other mucosal lesions.
- severe periodontal inflammation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Salivary 8-Hydroxy-2-Deoxyguanosine and Total Antioxidant Capacity in Patients With Oral Premalignant and Malignant Lesions
Objectives: Investigating the level of salivary 8-hydroxy-2-deoxyguanosine (8-OHdG) and total antioxidant capacity (TAC) in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant patients. Design: 120 subjects diagnosed with oral leukoplakia, oral lichen planus (OLP) and oral squamous cell carcinoma (OSCC) along with healthy control subjects were included. Salivary samples from all participants were collected. 8-OHdG was measured by ELISA technique and the TAC level was assessed by a photometric test system.
Read the detailed description
Detection of molecular markers in saliva is superior to their detection in serum and other body fluids due to the fact of being an easy non-invasive tool requiring no training for its collection. Consequently, the aim of our work was to investigate salivary 8-OHdG and TAC in premalignant and malignant patients compared to normal subjects and to determine their diagnostic value for the malignant patients.
Methodology:
Study population:
A total of 120 subjects were enrolled in the present study. The clinically tested and confirmed subjects included Group A: 30 patients diagnosed with oral leukoplakia Group B: 30 patients suffering from oral lichen planus Group C: 30 patients having oral squamous cell carcinoma with the tongue being the most commonly affected site Group D: 30 age and gender matched individuals having no oral mucosal lesions acting as a control group.
Comprehensive oral diagnosis was done for all participating individuals. Biopsy specimens were obtained from various lesions where a surgical double wedge incisional biopsy was carried out to a depth of about 2mm. Specimens were sent for histopathological examination to confirm the clinical diagnosis.
Salivary sample collection: Collection of whole unstimulated saliva from all participants was performed using standard techniques.Subjects refrained from eating, drinking, chewing gum etc., for at least ½ h before the evaluation.Samples were collected by asking individuals to swallow first, tilt their head forward and expectorate all saliva in a tube for 5 minutes without swallowing. After collection, all samples were immediately stored at -20ºC until assayed.
Detection of salivary 8-OHdG: Saliva was centrifuged for 5 minutes at 5000 x g. The supernatant was removed for determination of 8- hydroxy-2'-deoxyguanosine using an ELISA kit provided by BioVision, USA (Catalog # K4160-100). 8-hydroxy-2'-deoxyguanosine is an oxidized derivative of deoxyguanosine and is one of the major products of DNA oxidation.
Determination of salivary total antioxidative status/capacity (TAS/TAC) was done using ImAnOx (TAS/TAC) Kit provided by Immun Diagnostik, Germany. It is a photometric test system used for the determination of the total antioxidative status/capacity in EDTA-plasma, serum and other biological samples.
The determination of the antioxidative capacity was performed by the reaction of antioxidants in the sample with a defined amount of exogenously provided hydrogen peroxide (H2O2). The antioxidants in the sample eliminate a certain amount of the provided H2O2. The residual H2O2 was determined photometrically by an enzymatic reaction which involves the conversion of TMB to a colored product. After addition of a stop solution, the samples were measured at 450 nm in a microtiter plate reader. The quantification was performed by the delivered calibrator. The difference between applied and measured peroxide concentration in a defined time period is proportional to the reactivity of the antioxidants of the sample (antioxidative capacity). Quantification was performed with the enclosed calibrator.
- Conditions
- Premalignant Lesion
- Keywords
- Squamous cell carcinoma, 8-hydroxy-2- deoxyguanosine, Antioxidant
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 30 patients diagnosed with oral leukoplakia | |
| Group B | 30 patients diagnosed with oral lichen planus | |
| Group C | 30 patients having oral squamous cell carcinoma with the tongue being the most commonly affected site | |
| Group D | 30 age and gender matched individuals having no oral mucosal lesions acting as a control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary 8-OHdG
8-OHdG have a critical role in the pathogenesis of malignant lesions
Measured: 1 year
salivary TAC
OSCC might be used as a tool to help diagnosis of OSCC but not to differentiate between various malignant grades
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Apr 2018
- Primary completion1 Oct 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premalignant LesionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandy Hassan, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830710
- Sponsor's protocol ID
- 1234
- Status last verified
- Feb 2019
- First submitted
- 28 Jan 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Salivary 8-Hydroxy-2-Deoxyguanosine and Total Antioxidant Capacity in Patients With Oral Premalignant and Malignant Lesions
- ClinicalTrials.gov ID
- NCT03830710
- Acronym / sponsor ID
- 1234
- Conditions
- Premalignant Lesion
- Keywords
- Squamous cell carcinoma, 8-hydroxy-2- deoxyguanosine, Antioxidant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 5 Feb 2019 (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.
Objectives: Investigating the level of salivary 8-hydroxy-2-deoxyguanosine (8-OHdG) and total antioxidant capacity (TAC) in oral premalignant and malignant lesions in order to determine their diagnostic value for the malignant patients. Design: 120 subjects diagnosed with oral leukoplakia, oral lichen planus (OLP) and oral squamous cell carcinoma (OSCC) along with healthy control subjects were included. Salivary samples from all participants were collected. 8-OHdG was measured by ELISA technique and the TAC level was assessed by a photometric test system.
Detailed description
Detection of molecular markers in saliva is superior to their detection in serum and other body fluids due to the fact of being an easy non-invasive tool requiring no training for its collection. Consequently, the aim of our work was to investigate salivary 8-OHdG and TAC in premalignant and malignant patients compared to normal subjects and to determine their diagnostic value for the malignant patients.
Methodology:
Study population:
A total of 120 subjects were enrolled in the present study. The clinically tested and confirmed subjects included Group A: 30 patients diagnosed with oral leukoplakia Group B: 30 patients suffering from oral lichen planus Group C: 30 patients having oral squamous cell carcinoma with the tongue being the most commonly affected site Group D: 30 age and gender matched individuals having no oral mucosal lesions acting as a control group.
Comprehensive oral diagnosis was done for all participating individuals. Biopsy specimens were obtained from various lesions where a surgical double wedge incisional biopsy was carried out to a depth of about 2mm. Specimens were sent for histopathological examination to confirm the clinical diagnosis.
Salivary sample collection: Collection of whole unstimulated saliva from all participants was performed using standard techniques.Subjects refrained from eating, drinking, chewing gum etc., for at least ½ h before the evaluation.Samples were collected by asking individuals to swallow first, tilt their head forward and expectorate all saliva in a tube for 5 minutes without swallowing. After collection, all samples were immediately stored at -20ºC until assayed.
Detection of salivary 8-OHdG: Saliva was centrifuged for 5 minutes at 5000 x g. The supernatant was removed for determination of 8- hydroxy-2'-deoxyguanosine using an ELISA kit provided by BioVision, USA (Catalog # K4160-100). 8-hydroxy-2'-deoxyguanosine is an oxidized derivative of deoxyguanosine and is one of the major products of DNA oxidation.
Determination of salivary total antioxidative status/capacity (TAS/TAC) was done using ImAnOx (TAS/TAC) Kit provided by Immun Diagnostik, Germany. It is a photometric test system used for the determination of the total antioxidative status/capacity in EDTA-plasma, serum and other biological samples.
The determination of the antioxidative capacity was performed by the reaction of antioxidants in the sample with a defined amount of exogenously provided hydrogen peroxide (H2O2). The antioxidants in the sample eliminate a certain amount of the provided H2O2. The residual H2O2 was determined photometrically by an enzymatic reaction which involves the conversion of TMB to a colored product. After addition of a stop solution, the samples were measured at 450 nm in a microtiter plate reader. The quantification was performed by the delivered calibrator. The difference between applied and measured peroxide concentration in a defined time period is proportional to the reactivity of the antioxidants of the sample (antioxidative capacity). Quantification was performed with the enclosed calibrator.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –30 patients diagnosed with oral leukoplakia |
| Group B | – | –30 patients diagnosed with oral lichen planus |
| Group C | – | –30 patients having oral squamous cell carcinoma with the tongue being the most commonly affected site |
| Group D | – | –30 age and gender matched individuals having no oral mucosal lesions acting as a control group |
Who may qualify
- Ages
- 35 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The included subjects were all assessed medically according to the modified Cornell Medical index (Kerr \& Millard, 1965).
Key inclusion criteria (1 listed)
- All included individuals were not under any current medication, suffering from any systemic condition or having any other oral mucosal disorder.
Key exclusion criteria (4 listed)
- Pregnant or lactating females
- subjects having systemic disorder or taking medications;
- subjects who suffer 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.
Primary outcome
Salivary 8-OHdG
Time frame: 1 year
8-OHdG have a critical role in the pathogenesis of malignant lesions
salivary TAC
Time frame: 1 year
OSCC might be used as a tool to help diagnosis of OSCC but not to differentiate between various malignant grades
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 20 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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 Premalignant Lesion, 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 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 20 Feb 2019. 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 8-OHdG (time frame: 1 year). 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 20 Feb 2019.