- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02323672
Salivary and Serum Levels of Chemerin and MMP-9 in Oral Premalignant and Malignant Lesions
February 9, 2017 updated by: Noha Ayman Ghallab, Cairo University
Salivary and Serum Levels of Chemerin and MMP-9 in Oral Precancer and Oral Squamous Cell Carcinoma.
45 individuals were subdivided into 3 groups, 15 patients with oral premalignant lesions, 15 patients with oral malignant lesions and 15 control individuals.
Levels of chemerin and MMP-9 were evaluated in serum and saliva of these subjects utilizing the ELISA technique.
Study Overview
Status
Completed
Conditions
Detailed Description
45 individuals were subdivided into 3 groups, 15 patients suffering from oral premalignant lesions, 15 patients suffering from oral malignant lesions and 15 individuals having age, gender and periodontal status matched with both patients groups acting as a control group.
Serum and whole unstimulated saliva samples were collected from all the included groups in order to determine chemerin and MMP-9 in serum and saliva utilizing the ELISA technique.
Study Type
Observational
Enrollment (Actual)
45
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
45 individuals were subdivided into 3 groups, 15 patients suffering from oral squamous cell carcinoma lesions, 15 patients suffering from oral premalignant lesions (OPL) and 15 individuals having age, gender and periodontal status matched with both patients groups acting as a control group.
Description
Inclusion Criteria:
- patients with oral premalignant lesions.
- patients with oral malignant lesions.
Exclusion Criteria:
- any systemic disease other than oral premalignant or malignant lesions. smokers. pregnant females. periodontal diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
oral premalignant patients
15 patients suffering from oral premalignant lesions as lichen planus, actinic keratosis, leukoplakia and erythroplakia.
|
oral malignant patients
15 patients suffering from oral malignant lesions
|
control subjects
15 individuals age, gender and periodontal status matched with oral premalignant and malignant patients and not suffering from any oral mucosal lesions or periodontal disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
salivary levels of chemerin in patients with oral premalignant and malignant lesions.
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum levels of chemerin in patients with oral premalignant and malignant lesions.
Time Frame: 1 day
|
1 day
|
serum levels of MMP-9 in patients with oral premalignant and malignant lesions.
Time Frame: morning visit
|
morning visit
|
salivary levels of MMP-9 in patients with oral premalignant and malignant lesions.
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Noha Ghallab, M.D., Associate Professor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Skrzeczynska-Moncznik J, Stefanska A, Zabel BA, Kapinska-Mrowiecka M, Butcher EC, Cichy J. Chemerin and the recruitment of NK cells to diseased skin. Acta Biochim Pol. 2009;56(2):355-60. Epub 2009 Jun 18.
- Parolini S, Santoro A, Marcenaro E, Luini W, Massardi L, Facchetti F, Communi D, Parmentier M, Majorana A, Sironi M, Tabellini G, Moretta A, Sozzani S. The role of chemerin in the colocalization of NK and dendritic cell subsets into inflamed tissues. Blood. 2007 May 1;109(9):3625-32. doi: 10.1182/blood-2006-08-038844. Epub 2007 Jan 3.
- Zhou XJ, Sugerman PB, Savage NW, Walsh LJ. Matrix metalloproteinases and their inhibitors in oral lichen planus. J Cutan Pathol. 2001 Feb;28(2):72-82. doi: 10.1034/j.1600-0560.2001.280203.x.
- Nanda DP, Dutta K, Ganguly KK, Hajra S, Mandal SS, Biswas J, Sinha D. MMP-9 as a potential biomarker for carcinoma of oral cavity: a study in eastern India. Neoplasma. 2014;61(6):747-57. doi: 10.4149/neo_2014_091.
- Wang N, Wang QJ, Feng YY, Shang W, Cai M. Overexpression of chemerin was associated with tumor angiogenesis and poor clinical outcome in squamous cell carcinoma of the oral tongue. Clin Oral Investig. 2014 Apr;18(3):997-1004. doi: 10.1007/s00784-013-1046-8. Epub 2013 Jul 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
December 18, 2014
First Submitted That Met QC Criteria
December 22, 2014
First Posted (Estimate)
December 23, 2014
Study Record Updates
Last Update Posted (Actual)
February 10, 2017
Last Update Submitted That Met QC Criteria
February 9, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- chemerin_MMP-9_Oral_cancer
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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