Oral Submucous Fibrosis Clinical Trial
Official title:
Risk Assessment of Malignant Transformation in Oral Submucous Fibrosis Using Epithelial Mesenchymal Transition (EMT) Signatures in Tissue Samples and Saliva
NCT number | NCT03732872 |
Other study ID # | Oxford DC |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 15, 2015 |
Est. completion date | March 20, 2018 |
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.
Status | Completed |
Enrollment | 185 |
Est. completion date | March 20, 2018 |
Est. primary completion date | December 28, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Any patient who had history of arecanut chewing habit with clinical manifestations of OSMF. - 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 had bleeding disorders - patients who are diagnosed with salivary gland disorders that can alter salivary flow or composition |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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The Oxford Dental College, Hospital and Research Center, Bangalore, India | Credora Life Sciences, India |
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Expression of E-cadherin levels in all the groups in IHC | For IHC: The criteria used to define E-cadherin positive cells was brown staining in cell membrane of epithelial cells; the percentage of positively stained cells were scored as - Percentage of POSITIVE CELLS SCORE No cells 0 = 10% 1 11% -50 % 2 51%-80% 3 =81% 4 Staining Intensity was also assessed in comparison with the positive control tissue and scored accordingly INTENSITY SCORE Negative 0 Weak 1 Moderate 2 Strong 3 |
10 days from sample collection | |
Primary | Change in Expression of vimentin levels in all the groups in IHC | vimentin positive cells was brown staining in cytoplasm of epithelial cells; the percentage of positively stained cells were scored as - Percentage of POSITIVE CELLS SCORE No cells 0 = 10% 1 11% -50 % 2 51%-80% 3 =81% 4 Staining Intensity was also assessed in comparison with the positive control tissue and scored accordingly INTENSITY SCORE Negative 0 Weak 1 Moderate 2 Strong 3 |
10 days from sample collection | |
Primary | Change in Expression of collagen IV levels in all the groups in IHC | collagen IV positive cells was brown staining in basement membrane cells; the percentage of positively stained cells were scored as - Percentage of POSITIVE CELLS SCORE No cells 0 = 10% 1 11% -50 % 2 51%-80% 3 =81% 4 Staining Intensity was also assessed in comparison with the positive control tissue and scored accordingly INTENSITY SCORE Negative 0 Weak 1 Moderate 2 Strong 3 |
10 days from sample collection | |
Primary | Change in Expression of miRNA 21 in all three groups using Real Time-PCR | Considering the expression of miRNA21 in normal sample (N) as 1, the expression of all the samples were calculated The formula used is: number of copies = (amount * 6.022x1023) / (length * 1x109 * 650) | 10 days from sample collection | |
Primary | CHange in E cadherin levels in PCR | After extraction of DNA from biopsy samples the primers for E-cadherin were designed using Primer Express software, synthesized and HPLC purified for real time PCR for quantification. | 20 days after sample collection | |
Primary | Change in vimentin levels in PCR | After extraction of DNA from the biopsy samples the primers for Vimentin were designed using Primer Express software, synthesized and HPLC purified for real time PCR for quantification | 20 days after sample collection | |
Secondary | Change in e-cadherin expression with respect to disease category clinically in OSMF patients with habits | E cadherin level in tissue samples with respect to different Clinical expression of disease according to Kerr et al classification system. | 15 days from sample collection | |
Secondary | Change in e-cadherin expression with respect to disease category histologically in OSMF patients with habits | E cadherin level in tissue samples with respect to different Clinical expression of disease according to Kanna and Andrade et al classification system. | 15 days from sample collection | |
Secondary | Change in vimentin expression with respect to disease category clinically in OSMF patients with habits | Vimentin level in tissue samples with respect to different Clinical expression according to Kerr et al classification system. | 15 days from sample collection | |
Secondary | Change in vimentin expression with respect to disease category histologically in OSMF patients with habits | Vimentin level in tissue samples with respect to different histological expression according to Khanna and Andrade classification system. | 15 days from sample collection | |
Secondary | Change in collagen IV expression with respect to disease category clinically in OSMF patients with habits | Collagen-IV level in tissue samples with respect to different Clinical expression category according to Kerr et al classification system. | 15 days from sample collection | |
Secondary | Change in collagen IV expression with respect to disease category hstologically in OSMF patients with habits | Collagen-IV level in tissue samples with respect to different histological expression according to Khanna and Andred et al classification system. | 15 days from sample collection | |
Secondary | Change in mi RNA 21 expression with respect to disease category clinically in OSMF patients with habits | miRNA 21 level in saliva samples with respect to different Clinical expression of OSMF according to Kerr et al classification system. | 15 days from sample collection | |
Secondary | Change in mi RNA 21 expression with respect to disease category histologically in OSMF patients with habits | miRNA 21 level in saliva samples with respect to different histological expression according to Khanna and Andred et al classification system. | 15 days from sample collection |
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