Clinical trial NCT02323672: Salivary and Serum Levels of Chemerin and MMP-9 in Oral Premalignant and Malignant Lesions
Official title: Salivary and Serum Levels of Chemerin and MMP-9 in Oral Precancer and Oral Squamous Cell Carcinoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Precancerous Conditions
Oral Cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: salivary levels of chemerin in patients with oral premalignant and malignant lesions.
timeFrame: 1 day
Secondary outcomes:
measure: serum levels of chemerin in patients with oral premalignant and malignant lesions.
timeFrame: 1 day
measure: serum levels of MMP-9 in patients with oral premalignant and malignant lesions.
timeFrame: morning visit
measure: salivary levels of MMP-9 in patients with oral premalignant and malignant lesions.
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
name: Noha Ghallab, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.