Oral Submucous FibrosisNCT03732872
Epithelial Mesenchymal Transition Markers in OSMF
An observational study of Oral Submucous Fibrosis, run by The Oxford Dental College, Hospital and Research Center, Bangalore, India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Submucous Fibrosis
- What is being tested?
- Biopsy tissue analysis and Saliva analysis
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2015to 20 Mar 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects were selected from outpatient department of Dental College OPD
Who may be able to join
- 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
Who cannot join
- Patients who had bleeding disorders
- patients who are diagnosed with salivary gland disorders that can alter salivary flow or composition
About this study
Official title: Risk Assessment of Malignant Transformation in Oral Submucous Fibrosis Using Epithelial Mesenchymal Transition (EMT) Signatures in Tissue Samples and Saliva
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.
Read more
Research question was:
- Is EMT a positive signature in OSMF.
- Does histopathological grading and dysplasia in OSMF have any correlation with EMT.
- Can aberrant EMT markers be a reliable indicator for risk assessment of early malignant transformation.
- Can expression of mi RNA 21 in saliva predict the disease severity and more importantly assess risk of early malignant transformation in OSMF.
Read the detailed description
Epithelial-mesenchymal transition (EMT) describes the process whereby cells shed their epithelial properties and adopt a more mesenchymal and invasive phenotype. A continuous molecular cross talk between epithelial and mesenchymal cells is required during embryonic development (epithelial mesenchymal transition) and probably plays an important role in pathologic process like wound healing and tumour progression. The development of carcinomas is due to the genetic changes within the target epithelium. As there is conversion of normal epithelium to potentially malignant and to squamous cell carcinoma, the stroma also changes from normal to activated or tumor associated called as the stromal reaction. 10 EMT can generate mesenchymal cells that express α-smooth muscle actin (αSMA), as seen in myofibroblasts. It is, however, unclear whether functional myofibroblasts seen in fibrosis or cancer derived from epithelial or endothelial cells
Hence EMT markers in OSMF were assessed in this study. the following markers chosen as:
- 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.
- 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
- 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
- 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
- Oral Submucous Fibrosis
- Being tested
- Biopsy tissue analysis, Saliva analysis
- Keywords
- OSMF, EMT, miRNA 21, vimentin, e-cadherin
- Medical subject headings
- Oral Submucous Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy tissue analysisDiagnostic test
biopsy samples for IHC staining and PCR
Saliva analysisDiagnostic test
Saliva samples for miRNA 21 expression analysis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Biopsy tissue analysis; Diagnostic Test: Saliva 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 Receives: Diagnostic Test: Biopsy tissue analysis; Diagnostic Test: Saliva analysis | |
| Healthy human volunteers | patients who reported no history of areacnut chewing habits and had no clinical symptoms of OSMF Receives: Diagnostic Test: Biopsy tissue analysis; Diagnostic Test: Saliva analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days from sample collection
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
Measured: 10 days from sample collection
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
Measured: 10 days from sample collection
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)
Measured: 10 days from sample collection
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.
Measured: 20 days after sample collection
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
Measured: 20 days after sample collection
Secondary outcomes (8)
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.
Measured: 15 days from sample collection
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.
Measured: 15 days from sample collection
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.
Measured: 15 days from sample collection
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.
Measured: 15 days from sample collection
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.
Measured: 15 days from sample collection
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.
Measured: 15 days from sample collection
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.
Measured: 15 days from sample collection
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.
Measured: 15 days from sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start15 Jan 2015
- Primary completion28 Dec 2017
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Submucous FibrosisStudies of the same condition, open and under way.
- 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Oxford Dental College, Hospital and Research Center, Bangalore, India
- Sponsor type
- University, hospital or other
- Collaborators
- Credora Life Sciences, India
- Responsible party
- Principal investigator, Dr. Shesha Prasad, The Oxford Dental College, Hospital and Research Center, Bangalore, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732872
- Sponsor's protocol ID
- Oxford DC
- Status last verified
- Nov 2018
- First submitted
- 27 Oct 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23510112Sawant 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.
PubMed 23865921Pinto 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.
PubMed 10349192
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment of Malignant Transformation in Oral Submucous Fibrosis Using Epithelial Mesenchymal Transition (EMT) Signatures in Tissue Samples and Saliva
- ClinicalTrials.gov ID
- NCT03732872
- Acronym / sponsor ID
- Oxford DC
- Conditions
- Oral Submucous Fibrosis
- Keywords
- OSMF, EMT, miRNA 21, vimentin, e-cadherin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- The Oxford Dental College, Hospital and Research Center, Bangalore, IndiaUniversity, hospital or other
- Collaborators
- Credora Life Sciences, India
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 7 Nov 2018 (actual)
- 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.
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:
- Is EMT a positive signature in OSMF.
- Does histopathological grading and dysplasia in OSMF have any correlation with EMT.
- Can aberrant EMT markers be a reliable indicator for risk assessment of early malignant transformation.
- Can expression of mi RNA 21 in saliva predict the disease severity and more importantly assess risk of early malignant transformation in OSMF.
Detailed description
Epithelial-mesenchymal transition (EMT) describes the process whereby cells shed their epithelial properties and adopt a more mesenchymal and invasive phenotype. A continuous molecular cross talk between epithelial and mesenchymal cells is required during embryonic development (epithelial mesenchymal transition) and probably plays an important role in pathologic process like wound healing and tumour progression. The development of carcinomas is due to the genetic changes within the target epithelium. As there is conversion of normal epithelium to potentially malignant and to squamous cell carcinoma, the stroma also changes from normal to activated or tumor associated called as the stromal reaction. 10 EMT can generate mesenchymal cells that express α-smooth muscle actin (αSMA), as seen in myofibroblasts. It is, however, unclear whether functional myofibroblasts seen in fibrosis or cancer derived from epithelial or endothelial cells
Hence EMT markers in OSMF were assessed in this study. the following markers chosen as:
- 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.
- 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
- 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
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient with habits and having OSMF | – | Diagnostic Test: Biopsy tissue analysis, Diagnostic Test: Saliva analysisPatients 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 |
| Patients with habits and had no clinical symptoms of OSMF | – | Diagnostic Test: Biopsy tissue analysis, Diagnostic Test: Saliva analysisPatients who had history of arecanut chewing habit in any form and composition and had no symptoms of OSMF clinically |
| Healthy human volunteers | – | Diagnostic Test: Biopsy tissue analysis, Diagnostic Test: Saliva analysispatients who reported no history of areacnut chewing habits and had no clinical symptoms of OSMF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were selected from outpatient department of Dental College OPD
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who had bleeding disorders
- patients who are diagnosed with salivary gland disorders that can alter salivary flow or composition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy tissue analysisbiopsy samples for IHC staining and PCR | Diagnostic test | Healthy human volunteers, Patient with habits and having OSMF, Patients with habits and had no clinical symptoms of OSMF |
| Saliva analysisSaliva samples for miRNA 21 expression analysis | Diagnostic test | Healthy human volunteers, Patient with habits and having OSMF, Patients with habits and had no clinical symptoms of OSMF |
Primary outcome
Change in Expression of E-cadherin levels in all the groups in IHC
Time frame: 10 days from sample collection
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
Change in Expression of vimentin levels in all the groups in IHC
Time frame: 10 days from sample collection
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
Change in Expression of collagen IV levels in all the groups in IHC
Time frame: 10 days from sample collection
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
Change in Expression of miRNA 21 in all three groups using Real Time-PCR
Time frame: 10 days from sample collection
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)
CHange in E cadherin levels in PCR
Time frame: 20 days after sample collection
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.
Change in vimentin levels in PCR
Time frame: 20 days after sample collection
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
8 secondary outcomes
Change in e-cadherin expression with respect to disease category clinically in OSMF patients with habits
Time frame: 15 days from sample collection
Change in e-cadherin expression with respect to disease category histologically in OSMF patients with habits
Time frame: 15 days from sample collection
Change in vimentin expression with respect to disease category clinically in OSMF patients with habits
Time frame: 15 days from sample collection
Change in vimentin expression with respect to disease category histologically in OSMF patients with habits
Time frame: 15 days from sample collection
Change in collagen IV expression with respect to disease category clinically in OSMF patients with habits
Time frame: 15 days from sample collection
Change in collagen IV expression with respect to disease category hstologically in OSMF patients with habits
Time frame: 15 days from sample collection
Change in mi RNA 21 expression with respect to disease category clinically in OSMF patients with habits
Time frame: 15 days from sample collection
Change in mi RNA 21 expression with respect to disease category histologically in OSMF patients with habits
Time frame: 15 days from sample collection
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 7 Nov 2018.
- Background: PubMed 23510112Yang 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.
- Background: PubMed 23865921Sawant 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.
- Background: PubMed 10349192Pinto 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Submucous Fibrosis, run by The Oxford Dental College, Hospital and Research Center, Bangalore, India.
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 3 inclusion and 2 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 7 Nov 2018. 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?
Change in Expression of E-cadherin levels in all the groups in IHC (time frame: 10 days from sample collection). The study lists 6 primary outcomes in all. 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 NCT03732872, which also lists 3 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 7 Nov 2018.