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CTRI Number  CTRI/2024/04/065199 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 09/03/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational prospective study 
Study Design  Other 
Public Title of Study   Genetics of thick tumors in head and neck cancers 
Scientific Title of Study   Determining various molecular/genetic changes associated with > 10mm depth of invasion in head and neck malignancies 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Samir Gupta 
Designation  Professor and Head 
Affiliation  DY Patil Medical College 
Address  OPD no 15, Department of Surgical Oncology, Hitech building, DY Patil Medical College, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
412303
India 
Phone  9815128171  
Fax    
Email  samiranu1991@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Samir Gupta 
Designation  Professor and Head 
Affiliation  DY Patil Medical College 
Address  OPD no 15, Department of Surgical Oncology, Hitech building, DY Patil Medical College, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
412303
India 
Phone  9815128171  
Fax    
Email  samiranu1991@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Samir Gupta 
Designation  Professor and Head 
Affiliation  DY Patil Medical College 
Address  OPD no 15, 2nd floor, Hi tech building, DY Patil Medical College, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
412303
India 
Phone  9815128171  
Fax    
Email  samiranu1991@gmail.com  
 
Source of Monetary or Material Support  
DY Patil University Seed Money, DPU campus, Sant Tukaram Nagar, Pimpri, Pune, Maharastra Pin: 412303 
 
Primary Sponsor  
Name  DY Patil University 
Address  Sant Tukaram Nagar, Pimpri, Pune 
Type of Sponsor  Research institution and hospital 
 
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 Samir Gupta  DY Patil Medical College  OPD no 15, 2nd floor, Hitech building, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA 		 9815128171

samiranu1991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Dr. D Y Patil VIdyapeeth, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All patients of oral cancers undergoing surgery in our department 
 
ExclusionCriteria 
Details  Palliative resection and metastatic patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find various genetic mutation or molecular changes found in head and neck cancer cells having depth of invasion more than 10 mm  Patient will be accessed, at presentation, after completion of treatment, at 3 months, at 6 months, at 12 months and at 2nd year.
All follow ups will be as per standard protocol for disease follow up and no extra follow for study will be done unless indicated clinically.
Genetic analysis will be done on tumor tissue blocks once histopathology report of tumor is available. 
 
Secondary Outcome  
Outcome  TimePoints 
To find any targetable molecular change associated with head and neck cancers having depth of invasion more than 10 mm  At the end of 2 years 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/04/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 04-04-2026 and end date provided 04-04-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Patients will be divided into those having depth of invasion less than 10 mm and equal to or more than 10 mm as per final histopathology report post surgical excision. Genetic/ molecular changes in these patients will be compared and analyzed. patients will be followed prospectively till 2 years and clinicopatholgoical correlation with tumor genetics will be done. 
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