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Epithelial Mesenchymal Transition Markers in OSMF

NCT03732872 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 185

Last updated 2018-11-07

No results posted yet for this study

Summary

Oral Sub mucous Fibrosis (OSMF) is essentially an imbalance between collagen metabolism and wound healing mechanism induced by arecanut chewing habit. Clinically the disease progresses in stages with patients presenting with burning sensation, intolerance to spicy food, vesicles particularly on the palate, ulceration and dryness of the mouth , fibrosis of the oral mucosa, leading to lips, tongue, and palate rigidity and finally trismus. As the disease is progressively debilitating and has potential to turn in to malignant cancer a study was designed to assess if there any tissue or saliva markers that can be assessed for early diagnosis and indicate malignant transformation if any.

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.

Conditions

  • Oral Submucous Fibrosis

Interventions

DIAGNOSTIC_TEST

Biopsy tissue analysis

biopsy samples for IHC staining and PCR

DIAGNOSTIC_TEST

Saliva analysis

Saliva samples for miRNA 21 expression analysis

Sponsors & Collaborators

  • Credora Life Sciences, India

    collaborator UNKNOWN

  • The Oxford Dental College, Hospital and Research Center, Bangalore, India

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-15
Primary Completion
2017-12-28
Completion
2018-03-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03732872 on ClinicalTrials.gov