Precancerous ConditionsNCT02323672
Salivary and Serum Levels of Chemerin and MMP-9 in Oral Premalignant and Malignant Lesions
An observational study of Precancerous Conditions and Oral Cancer, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Precancerous Conditions, Oral Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Oct 2014
- 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 40 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- patients with oral premalignant lesions.
- patients with oral malignant lesions.
Who cannot join
- any systemic disease other than oral premalignant or malignant lesions. smokers. pregnant females. periodontal diseases.
About this study
Official title: 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.
Read the 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.
- Conditions
- Precancerous Conditions, Oral Cancer
- Medical subject headings
- Precancerous Conditions, Mouth Neoplasms
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
salivary levels of chemerin in patients with oral premalignant and malignant lesions.
Measured: 1 day
Secondary outcomes (3)
serum levels of chemerin in patients with oral premalignant and malignant lesions.
Measured: 1 day
serum levels of MMP-9 in patients with oral premalignant and malignant lesions.
Measured: morning visit
salivary levels of MMP-9 in patients with oral premalignant and malignant lesions.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Precancerous ConditionsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ayman Ghallab, Cairo University
- Investigators
- Noha Ghallab, M.D., Principal investigator, Associate Professor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323672
- Sponsor's protocol ID
- chemerin_MMP-9_Oral_cancer
- Status last verified
- Feb 2017
- First submitted
- 18 Dec 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19543554Parolini 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.
PubMed 17202316Zhou 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.
PubMed 11168755Nanda 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.
PubMed 25150320Wang 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.
PubMed 23868294
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary and Serum Levels of Chemerin and MMP-9 in Oral Precancer and Oral Squamous Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT02323672
- Acronym / sponsor ID
- chemerin_MMP-9_Oral_cancer
- Conditions
- Precancerous Conditions, Oral Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Dec 2014 (estimated)
- 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- patients with oral premalignant lesions.
- patients with oral malignant lesions.
Key exclusion criteria (1 listed)
- any systemic disease other than oral premalignant or malignant lesions. smokers. pregnant females. periodontal diseases.
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 levels of chemerin in patients with oral premalignant and malignant lesions.
Time frame: 1 day
3 secondary outcomes
serum levels of chemerin in patients with oral premalignant and malignant lesions.
Time frame: 1 day
serum levels of MMP-9 in patients with oral premalignant and malignant lesions.
Time frame: morning visit
salivary levels of MMP-9 in patients with oral premalignant and malignant lesions.
Time frame: 1 day
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 10 Feb 2017.
- Background: PubMed 19543554Skrzeczynska-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.
- Background: PubMed 17202316Parolini 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.
- Background: PubMed 11168755Zhou 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.
- Background: PubMed 25150320Nanda 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.
- Background: PubMed 23868294Wang 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.
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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.
Noha Ghallab, M.D. principal investigator
Associate Professor of periodontology and Oral Medicine faulty of oral and dental medicine Cairo Unv.
Questions about this trial
What is this clinical trial studying?
An observational study of Precancerous Conditions and Oral Cancer, run by Cairo University.
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 2 inclusion and 1 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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 levels of chemerin in patients with oral premalignant and malignant lesions. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323672, which also lists 5 linked publications.
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 10 Feb 2017.