Oral Submucous FibrosisNCT03011086
Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis
An observational study of Oral Submucous Fibrosis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in India.
Trial summary
The etiology of OSMF is considered to be multifactorial. However, Role of autoimmunity had been suggested as one of the factors but remains unproven. The present study is undertaken to evaluate the presence of auto antibodies in OSMF patients to pave a way for new arena of treatment with the etiology of this… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Submucous Fibrosis
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2015to Dec 2017
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total number of patients were 70 patients (Group A- 35 OSMF patients, Group B- 35 controls) of both the genders
Who may be able to join
- Patients who are willing for the study.
- A positive history of chewing arecanut, and/or smoking tobacco and alcohol.
- Patients with clinical and histopathological features of oral submucous fibrosis.
- Patients with OSMF not under any treatment for the same
Who cannot join
- Unwilling patients who do not want to be part of the study.
- Patients with known autoimmune disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis - a Clinico-pathological Study
The etiology of OSMF is considered to be multifactorial. However, Role of autoimmunity had been suggested as one of the factors but remains unproven.
The present study is undertaken to evaluate the presence of auto antibodies in OSMF patients to pave a way for new arena of treatment with the etiology of this persistent condition
Read the detailed description
Oral submucous fibrosis (OSMF) is a potentially malignant disorder affecting any part of the oral cavity, sometimes pharynx associated with juxta epithelial fibrosis causing progressive trismus leading to dysphagia. It is mainly seen in the Asian countries with more prevalence in India.
Etiology of OSMF is considered to be multifactorial. However, it is strongly associated with the use of arecanut in various forms and also in combination with other compounding factors. Autoimmunity had been suggested as one of the factors yet unproven.
Few studies reveal that there is high incidence of Autoantibodies including antinuclear (ANA), Anti smooth muscle (SMA), Anti thyroid microsomal (TMA), and anti reticulin antibodies in OSMF patients. These findings have not been consistent in further studies which needs further more research in this.
A study concentrated on quantitation of circulating immune complexes (CIC) levels which was established in patients with oral cancer and oral precancerous lesions. The levels were compared with that in normal controls and chronic chewers of betel quid with no signs of any disease. Both patients with oral cancer and oral precancerous lesions had elevated CIC when compared to both the control groups. The most interesting observations were (a) the CIC levels in the chewing controls were significantly raised when compared to normal controls; and (b) the CIC levels in the patients with premalignant lesions were elevated almost to the same levels as in the oral cancer patients.
HLA-typing was carried on areca nut chewers. however, it was unable to demonstrate a specific pattern of HLA-antigen frequencies in chewers with or without the disease. It is not necessarily a HLA-associated susceptibility in Oral Submucous Fibrosis.
Due to less number of articles published on autoantibodies, this study is done to evaluate the presence of such auto antibodies in OSMF patients thereby paving way for new arena of treatment on par with the etiology of this persistent condition.
- Conditions
- Oral Submucous Fibrosis
- Keywords
- Autoantibodies, Oral Submucous Fibrosis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| oral sub mucous fibrosis | patients suffering with oral sub mucous fibrosis due to gutka/pan chewing confirmed by clinical examination | |
| control group | patients having gutka/ pan chewing habit without oral sub mucous fibrosis in oral cavity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of auto antibodies in oral sub mucous fibrosis
The subjects in the study suffering from oral submucous fibrosis will be clinically evaluated and graded based on criteria given by Khanna et al classification. All the subjects included in the study will also be subjected to serum analysis for presence of auto antibodies in their serum by Titerplane technique.
Measured: one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2015
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NALLAN CHAITANYA, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- NALLAN CHAITANYA, MDS, Principal investigator, ASSOCIATE PROFESSOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011086
- Sponsor's protocol ID
- PMVIDS/OMR/0016/2014
- Status last verified
- Dec 2017
- First submitted
- 7 Nov 2016
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis - a Clinico-pathological Study
- ClinicalTrials.gov ID
- NCT03011086
- Acronym / sponsor ID
- PMVIDS/OMR/0016/2014
- Conditions
- Oral Submucous Fibrosis
- Keywords
- Autoantibodies, Oral Submucous Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Jan 2017 (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.
The etiology of OSMF is considered to be multifactorial. However, Role of autoimmunity had been suggested as one of the factors but remains unproven.
The present study is undertaken to evaluate the presence of auto antibodies in OSMF patients to pave a way for new arena of treatment with the etiology of this persistent condition
Detailed description
Oral submucous fibrosis (OSMF) is a potentially malignant disorder affecting any part of the oral cavity, sometimes pharynx associated with juxta epithelial fibrosis causing progressive trismus leading to dysphagia. It is mainly seen in the Asian countries with more prevalence in India.
Etiology of OSMF is considered to be multifactorial. However, it is strongly associated with the use of arecanut in various forms and also in combination with other compounding factors. Autoimmunity had been suggested as one of the factors yet unproven.
Few studies reveal that there is high incidence of Autoantibodies including antinuclear (ANA), Anti smooth muscle (SMA), Anti thyroid microsomal (TMA), and anti reticulin antibodies in OSMF patients. These findings have not been consistent in further studies which needs further more research in this.
A study concentrated on quantitation of circulating immune complexes (CIC) levels which was established in patients with oral cancer and oral precancerous lesions. The levels were compared with that in normal controls and chronic chewers of betel quid with no signs of any disease. Both patients with oral cancer and oral precancerous lesions had elevated CIC when compared to both the control groups. The most interesting observations were (a) the CIC levels in the chewing controls were significantly raised when compared to normal controls; and (b) the CIC levels in the patients with premalignant lesions were elevated almost to the same levels as in the oral cancer patients.
HLA-typing was carried on areca nut chewers. however, it was unable to demonstrate a specific pattern of HLA-antigen frequencies in chewers with or without the disease. It is not necessarily a HLA-associated susceptibility in Oral Submucous Fibrosis.
Due to less number of articles published on autoantibodies, this study is done to evaluate the presence of such auto antibodies in OSMF patients thereby paving way for new arena of treatment on par with the etiology of this persistent condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral sub mucous fibrosis | – | –patients suffering with oral sub mucous fibrosis due to gutka/pan chewing confirmed by clinical examination |
| control group | – | –patients having gutka/ pan chewing habit without oral sub mucous fibrosis in oral cavity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total number of patients were 70 patients (Group A- 35 OSMF patients, Group B- 35 controls) of both the genders
Key inclusion criteria (4 listed)
- Patients who are willing for the study.
- A positive history of chewing arecanut, and/or smoking tobacco and alcohol.
- Patients with clinical and histopathological features of oral submucous fibrosis.
- Patients with OSMF not under any treatment for the same
Key exclusion criteria (2 listed)
- Unwilling patients who do not want to be part of the study.
- Patients with known autoimmune disorders.
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
Evaluation of auto antibodies in oral sub mucous fibrosis
Time frame: one and half year
The subjects in the study suffering from oral submucous fibrosis will be clinically evaluated and graded based on criteria given by Khanna et al classification. All the subjects included in the study will also be subjected to serum analysis for presence of auto antibodies in their serum by Titerplane technique.
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 19 Dec 2017.
- Individual participant dataSharing planned: No
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EVALUATION OF SALIVA AS LIQUID BIOPSY FOR EARLY DETECTION OF ORAL CANCER IN PATIENTS WITH ORAL-SUBMUCOUS FIBROSIS (OSMF)
The Study Focuses on the Saliva as Potential Source of Early Detection of Oral Cancer
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.
NALLAN CHAITANYA, MDS principal investigator
ASSOCIATE PROFESSOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Submucous Fibrosis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre at 1 site in 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 4 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 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Evaluation of auto antibodies in oral sub mucous fibrosis (time frame: one and half year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2017.