NCT02323672

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

December 18, 2014

Last Update Submit

February 9, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • salivary levels of chemerin in patients with oral premalignant and malignant lesions.

    1 day

Secondary Outcomes (3)

  • serum levels of chemerin in patients with oral premalignant and malignant lesions.

    1 day

  • serum levels of MMP-9 in patients with oral premalignant and malignant lesions.

    morning visit

  • salivary levels of MMP-9 in patients with oral premalignant and malignant lesions.

    1 day

Study Arms (3)

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.

Eligibility Criteria

Age40 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • patients with oral premalignant lesions.
  • patients with oral malignant lesions.

You may not qualify if:

  • any systemic disease other than oral premalignant or malignant lesions. smokers. pregnant females. periodontal diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 19543554BACKGROUND
  • 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.

    PMID: 17202316BACKGROUND
  • 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.

    PMID: 11168755BACKGROUND
  • 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.

    PMID: 25150320BACKGROUND
  • 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.

    PMID: 23868294BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and whole unstimulated saliva

MeSH Terms

Conditions

Precancerous ConditionsMouth Neoplasms

Condition Hierarchy (Ancestors)

NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteMouth DiseasesStomatognathic Diseases

Study Officials

  • Noha Ghallab, M.D.

    Associate Professor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of periodontology and Oral Medicine, faculty of oral and dental medicine

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 23, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

February 10, 2017

Record last verified: 2017-02