Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
185 participants
OBSERVATIONAL
2015-01-15
2018-03-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Participants who had OSMF and habit history, patients without OSMF but habit history formed the case group where as normal patients without OSMF and no habit history were in control group. Eligible candidates who consented to participate in study were subjected to biopsy procedure and also their saliva samples were collected. Biopsy samples were subjected to immunohistochemistry (IHC) and polymerase chain reaction (PCR) to assess the EMT markers like vimentin, e-cadherin and collagen IV. miRNA copies were extracted from saliva and were subjected RT-PCR.
Research question was:
1. Is EMT a positive signature in OSMF.
2. Does histopathological grading and dysplasia in OSMF have any correlation with EMT.
3. Can aberrant EMT markers be a reliable indicator for risk assessment of early malignant transformation.
4. Can expression of mi RNA 21 in saliva predict the disease severity and more importantly assess risk of early malignant transformation in OSMF.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
EVALUATION OF SALIVA AS LIQUID BIOPSY FOR EARLY DETECTION OF ORAL CANCER IN PATIENTS WITH ORAL-SUBMUCOUS FIBROSIS (OSMF)
NCT07122128
Gross Examinations Versus Frozen Section for Assessment of Surgical Margins in Oral Cancers
NCT04809324
Autofluorescence Detection of Oral Malignancies and Database and Biospecimen Collection to Identify Biomarkers of Head and Neck Tumor Progression
NCT01531881
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
NCT00542373
Spectroscopy for Diagnostic Assessment of Oral Mucosal Lesions
NCT00507182
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Hence EMT markers in OSMF were assessed in this study. the following markers chosen as:
1. miRNA-21 regulates cell proliferation, apoptosis and the epithelial to mesenchymal transition during neoplastic progression and is up regulated in a variety of cancers.An increased expression of miRNA-21 is seen in myofibroblasts.12 Since we know the role of myofibroblasts in OSMF, salivary expression of mi RNA- 21 was included as marker.
2. Type IV collagen has the unique feature of self-associating through intramolecular covalent bonds, providing barrier and mechanical strength properties to basement membranes.The increased collagen deposition in OSMF involves numerous fibroblasts that are converted to myofibroblasts found in histologic sections of tissue specimens. an altered micro environment or stroma such as persistent myofibroblasts has been shown to result in tumorigenesis and tumor progression
3. Cadherins are a class of type-1 trans-membrane proteins known for its calcium-dependent cell-cell adhesion property. E-cadherins are members of this protein family found in epithelial cells which serve important roles in cell adhesion by ensuring that cells within tissues are bound together. The loss of E-cadherin function or expression has been implicated in cancer progression and metastasis.E-cadherin expression in the head and neck epithelium is essential for the morphogenesis and homeostasis of epithelial tissues. The cadherin-mediated cell-cell contacts are required for the anchorage-dependent growth of epithelial cells.
Hence lower expression of E- cadherin is a sign of loss of epithelial integrity
4. The intermediate filament protein vimentin is involved in the regulation of cell behavior, morphology, and mechanical properties. Vimentin is a EMT marker expressed in connective tissue. Expression of vimentin in epithelium is a positive signature of EMT, and its evaluation in OSMF can unveil the importance of EMT signature in oral fibrosis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patient with habits and having OSMF
Patients who had history of arecanut chewing habit in any form and composition and who were not undergone any treatment for their current condition i.e, OSMF
Biopsy tissue analysis
biopsy samples for IHC staining and PCR
Saliva analysis
Saliva samples for miRNA 21 expression analysis
Patients with habits and had no clinical symptoms of OSMF
Patients who had history of arecanut chewing habit in any form and composition and had no symptoms of OSMF clinically
Biopsy tissue analysis
biopsy samples for IHC staining and PCR
Saliva analysis
Saliva samples for miRNA 21 expression analysis
Healthy human volunteers
patients who reported no history of areacnut chewing habits and had no clinical symptoms of OSMF
Biopsy tissue analysis
biopsy samples for IHC staining and PCR
Saliva analysis
Saliva samples for miRNA 21 expression analysis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biopsy tissue analysis
biopsy samples for IHC staining and PCR
Saliva analysis
Saliva samples for miRNA 21 expression analysis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who had arecanut chewing habit history of more than 1 year and had no clinical symptoms of OSMF.
* Healthy human volunteers who are indicated for extraction of tooth and had no clinical features of OSMF and had no habit history
Exclusion Criteria
* patients who are diagnosed with salivary gland disorders that can alter salivary flow or composition
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Credora Life Sciences, India
UNKNOWN
The Oxford Dental College, Hospital and Research Center, Bangalore, India
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Shesha Prasad
Senior lecturer
References
Explore related publications, articles, or registry entries linked to this study.
Yang Y, Li YX, Yang X, Jiang L, Zhou ZJ, Zhu YQ. Progress risk assessment of oral premalignant lesions with saliva miRNA analysis. BMC Cancer. 2013 Mar 19;13:129. doi: 10.1186/1471-2407-13-129.
Sawant SS, Vaidya Mm, Chaukar DA, Alam H, Dmello C, Gangadaran P, Kannan S, Kane S, Dange PP, Dey N, Ranganathan K, D'Cruz AK. Clinical significance of aberrant vimentin expression in oral premalignant lesions and carcinomas. Oral Dis. 2014 Jul;20(5):453-65. doi: 10.1111/odi.12151. Epub 2013 Jul 19.
Pinto GA, Vassallo J, Andrade LA, Magna LA. Immunohistochemical study of basement membrane collagen IV in uterine cervix carcinoma. Sao Paulo Med J. 1998 Nov-Dec;116(6):1846-51. doi: 10.1590/s1516-31801998000600004.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Oxford DC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.