FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/02/031037 [Registered on: 05/02/2021] Trial Registered Prospectively
Last Modified On: 04/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Perineural invasion in oral squamous cell carcinoma. 
Scientific Title of Study   Perineural invasion and nerve morphometry in oral squamous cell carcinoma and their correlation with other prognostic markers – A cross-sectional study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prateek Sharma 
Designation  Junior Resident 
Affiliation  Rohilkhand Medical College & Hospital, Bareilly 
Address  60 shakti nagar, pilibhit bypass road, Bareilly, U.P.
Department of Pathology, Rohilkhand Medical College, Bareilly, U.P.
Bareilly
UTTAR PRADESH
243006
India 
Phone  7906138725  
Fax    
Email  prateeksharma0711@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mithila Bisht 
Designation  Professor 
Affiliation  Rohilkhand Medical College & Hospital, Bareilly 
Address  Department of Pathology, Rohilkhand Medical College, Bareilly, U.P.

Bareilly
UTTAR PRADESH
243006
India 
Phone  7906080213  
Fax    
Email  dr.mithila@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prateek Sharma 
Designation  Junior Resident 
Affiliation  Rohilkhand Medical College & Hospital, Bareilly 
Address  60 shakti nagar, pilibhit bypass road, Bareilly, U.P.
Department of Pathology, Rohilkhand Medical College, Bareilly, U.P.
Bareilly
UTTAR PRADESH
243006
India 
Phone  7906138725  
Fax    
Email  prateeksharma0711@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College, Bareilly. 
 
Primary Sponsor  
Name  Rohilkhand Medical College Hospital 
Address  4, Pilibhit bypass road, Opposite suresh sharma nagar, bareilly, U.P. 
Type of Sponsor  Private medical college 
 
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 
Prateek Sharma  Rohilkhand Medical College and Hospital  Department of Pathology.
Bareilly
UTTAR PRADESH 		 7906138725

prateeksharma0711@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RMCH, Bareilly  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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Biopsies from oral cavity diagnosed microscopically as oral squamous cell carcinoma during the study period. 
 
ExclusionCriteria 
Details  Cancers of oral cavity other than squamous cell carcinomas.
Inadequate biopsy specimen. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Perineural invasion, nerve morphometry and immunohistochemistry in oral squamous cell carcinoma.  Nil 
 
Secondary Outcome  
Outcome  TimePoints 
Patterns of PNI on microscopy along with measurement of nerve tumor distance and nerve diameter in PNI negative tumors on S100 stained slides.  Nil 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prateeksharma0711@gmail.com].

  6. For how long will this data be available start date provided 28-07-2022 and end date provided 28-12-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The oral cavity is formed by the arch of the hard and soft palate above, the teeth and cheeks laterally, and the tongue on the floor of the mouth. All oral lesions are divided in to three groups including non neoplastic lesions, potentially malignant disorders and neoplastic lesions.1 Neoplastic lesions include squamous cell carcinomas most commonly, papillomas, soft tissue and neural tumors ,oral mucosal melanomas, salivary type tumours and haematolymphoid tumors like lymphomas, extramedullary myeloid sarcoma.2 Oral cancer arising from the oral mucosal epithelium is a major health problem worldwide. It represents 2% of all new cancers worldwide.3 It is more common in men (5.5 cases per lakh population) than women (2.5 cases per lakh population).It is associated with severe morbidity ,recurrence and reduced survival rates. The most common cause of oral cancers are tobacco chewing and alcohol. Others are Human Papilloma Virus type 16, poor oral hygiene, occupational exposure, malnutrition, chronic irritation. Oral tumors shows exophytic or verrucous growth, most commonly seen in the tongue, floor of mouth and gingiva.4-5 Diagnosis of oral squamous cell carcinoma is confirmed by biopsy and histopathology. Histopathologically the SCC are classified as well, moderately differentiated, poorly differentiated.6
Conventionally oral SCC are aggressive and prognostic factors have an impact on its morbidity ,recurrence and encompass various clinicopathologic factors like grade ,tumour size, nodal status, distant metastasis, lymphovascular invasion(LVI), worst pattern of invasion(WPOI) and perineural invasion(PNI).PNI is a form of tumor spread exhibited by malignancies which are neurotropic in nature and correlates with aggressive behavior, disease reccurence and mortality. Incidenceof PNI in head and neck is as high as 80%.7
 
Close