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CTRI Number  CTRI/2022/10/046302 [Registered on: 10/10/2022] Trial Registered Prospectively
Last Modified On: 14/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of salivary biomarkers for early detection of oral cancer and precancerous conditions 
Scientific Title of Study   Evaluation of salivary gamma synuclein, IL-6 and IL-8 in patients with oral malignancies and potentially malignant oral disorders  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinayalekshmy I N Nair 
Designation  Junior resident  
Affiliation  Banaras Hindu University  
Address  Oral medicine and Radiology, Faculty of Dental Sciences, Institute of Medical sciences, Banaras Hindu University, Varanasi, Uttar Pradesh
85 B, Koshlesh nagar colony, Naria, Sunderpur, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India 
Phone  9656031235  
Fax    
Email  vinayalekshmynair@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Adit Srivastava  
Designation  Professor  
Affiliation  Banaras Hindu University  
Address  Oral medicine and Radiology, Faculty of Dental Sciences, Institute of Medical sciences, Banaras Hindu University, Varanasi, Uttar Pradesh

Varanasi
UTTAR PRADESH
221005
India 
Phone  9451525522  
Fax    
Email  adit@bhu.ac.in  
 
Details of Contact Person
Public Query
 
Name  Vinayalekshmy I N Nair 
Designation  Junior resident  
Affiliation  Banaras Hindu University  
Address  Oral medicine and Radiology, Faculty of Dental Sciences, Institute of Medical sciences, Banaras Hindu University, Varanasi, Uttar Pradesh
85 B, Koshlesh nagar colony, Naria, Sunderpur, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India 
Phone  9656031235  
Fax    
Email  vinayalekshmynair@gmail.com  
 
Source of Monetary or Material Support  
Monetary support by self and infrastructural support by Faculty of Dental Sciences Institute of Medical sciences Banaras Hindu University Varanasi Uttar Pradesh  
 
Primary Sponsor  
Name  Vinayalekshmy I N Nair 
Address  Junior resident, Oral medicine and Radiology, Faculty of Dental Sciences, Banaras Hindu University  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinayalekshmy I N Nair  Faculty of Dental Sciences, Institute of Medical sciences, Banaras Hindu University   Oral medicine and Radiology, Faculty of Dental Sciences, Institute of Medical sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH 
9656031235

vinayalekshmynair@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Oral malignancies
Potentially malignant oral disorders 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Level of salivary gamma synuclein, IL-6, IL-8   Before treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Levels of IL-6, levels of IL-8  Before treatment  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2022 
Date of Study Completion (India) 14/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/12/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Oral cancer is reported as the sixth most frequently occurring malignancy all over the world. The burden of oral cancer is much higher in developing countries compared to Western countries. This accounts for almost 40% of all cancers in the Indian subcontinent and contributed one-third of the world burden of oral cancer.
The common potentially malignant oral disorders (PMODs) seen in India such as leukoplakia, erosive lichen planus, oral submucous fibrosis are more likely to transform into malignancy than the general population, and PMODs are thus considered to be a warning sign for the development of OSCC.
Despite of recent therapeutic advances, oral cancer has one of the lowest survival rates. For oral squamous cell carcinoma (OSCC), the overall 5-year survival rate is approximately 50%, and unchanged over the last 30 years mainly due to delayed diagnosis, underdiagnosis or misdiagnosis.
But if the disease can be detected early, treatment can be given more effectively, and consequently the survival rate can also be
increased. For OSCCs which were detected early i.e soon after the transition from premalignancy, the survival rate after giving effective treatment has increased to about 80%. Thus, early diagnosis and
appropriate treatment at the right time is highly essential. This shows the importance of potentially malignant disorders which if diagnosed and treated early can reduce the incidence of oral carcinoma to a great extent.
At present, biopsy for histopathologic examination is used for the definite diagnosis of OSCC and PMODs.
But its disadvantages, includes that it is time-consuming, has a high cost, and isinvasive causing destruction to human tissues. Furthermore, some clinical auxiliary examinations for PMODs, such as autofluorescence imaging, aceto-whitening and toluidine blue in vivo staining, have poor diagnostic accuracy and give high
false-positive results. Therefore, finding a conventional diagnostic method with high sensitivity and specificity is extremely important for the diagnosis of OSCC and PMODs.
Considering the facts such as delayed detection likely to be a primary reason for the high morbidity and mortality rates of oral cancer patients and the disadvantages of the current diagnostic methods, there is a need for finding a new method to perk up early detection of oral cancers.
Biomarkers are measurable nano-protein which is used to predict a biological state. These can be detected in serum, saliva, and tissue using convenient and rapid methods. There is a constant search for biomarkers in saliva, a body fluid that can be easily collected, for noninvasive detection of oral cancer and precancer.
Levels of over 100 salivary biomarkers for oral malignancies have been identified as changing significantly in OSCC patients, but these markers exhibited a low value to detect OSCC. Therefore, it is needed to explore a more ideal marker for OSCC and PMODs. The diagnosis and prognosis prediction of oral cancer can be made simple by using saliva as a tool with the help of an ideal salivary biomarker. It should be a cost-effective method which could easily be employed to screen large populations.
The synuclein protein family is a small, soluble proteome composed of synuclein-α, synuclein-β and synuclein-γ (SNCG), originally found in brain tissue, peripheral nerve tissue, and retina, which is involved
in neurodegenerative diseases and cancers. SNCG expression is an early step in the malignant transformation of oral epithelium. Interleukin-6 (IL-6) and interleukin-8 (IL-8) are multifunctional cytokines that is associated with cancer in various ways. Recently, they are also found to be increased in the saliva of oral precancer and cancer patients, which could serve as a biomarker.The excessive production of IL-6 and IL-8 plays a role in cancer progression and establishment of angiogenesis. IL-8 levels are found to be same in serum and saliva and is elevated in PMODs making it as a valuable biomarker.
A study on evaluation of SNCG levels in saliva and cancer tissues from oral squamous cell carcinoma patients and another study on assessment of serum SNCG and squamous cell carcinoma antigen as diagnostic biomarkers in patients with PMODs and OSCC were conducted earlier, but no studies have been conducted to assess the level of salivary SNCG in patients with OSCC and PMODs and correlated the findings with levels of salivary IL-6 and IL-8 for identifying the diagnostic value of SNCG as a biomarker
as well as using the combination of salivary SNCG, IL-6 and IL-8 for diagnosis and prognosis of OSCCs and PMODs.

 
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