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8-Hydroxy-2-Deoxyguanosine ,Total Antioxidant Capacity in Oral Premalignant and Malignant Lesions

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ClinicalTrials.gov Identifier: NCT03830710
Recruitment Status : Completed
First Posted : February 5, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Sandy Hassan, Fayoum University

Brief 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. 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.

Condition or disease
Premalignant Lesion

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.


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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Detection of Salivary 8-Hydroxy-2-Deoxyguanosine and Total Antioxidant Capacity in Patients With Oral Premalignant and Malignant Lesions
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Group/Cohort
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



Primary Outcome Measures :
  1. Salivary 8-OHdG [ Time Frame: 1 year ]
    8-OHdG have a critical role in the pathogenesis of malignant lesions

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 63 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The included subjects were all assessed medically according to the modified Cornell Medical index (Kerr & Millard, 1965).
Criteria

Inclusion Criteria:

All included individuals were not under any current medication, suffering from any systemic condition or having any other oral mucosal disorder.

Exclusion Criteria:

  1. Pregnant or lactating females
  2. subjects having systemic disorder or taking medications;
  3. subjects who suffer from any other mucosal lesions.
  4. severe periodontal inflammation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830710


Locations
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Egypt
Sandy hassan shaaban
Cairo, Egypt
Sponsors and Collaborators
Fayoum University
  Study Documents (Full-Text)

Documents provided by Sandy Hassan, Fayoum University:
Statistical Analysis Plan  [PDF] April 1, 2018


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Responsible Party: Sandy Hassan, lecturer, Fayoum University
ClinicalTrials.gov Identifier: NCT03830710     History of Changes
Other Study ID Numbers: 1234
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sandy Hassan, Fayoum University:
Squamous cell carcinoma
8-hydroxy-2- deoxyguanosine
Antioxidant
Additional relevant MeSH terms:
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Precancerous Conditions
Neoplasms
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs