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CTRI Number  CTRI/2024/06/068568 [Registered on: 07/06/2024] Trial Registered Prospectively
Last Modified On: 01/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Techniques to achieve complete tumor removal when performing breast conserving surgery for breast cancer 
Scientific Title of Study   Techniques of achieving tumor free margins in breast conservative surgery 
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 Priyal Agarwal  
Designation  Junior Resident  
Affiliation  Kasturba Medical College and Kasturba Hospital, Manipal  
Address  Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7905262134  
Fax    
Email  priyal.kmcmpl2023@learner.maipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Stanley Mathew 
Designation  Professor of General Surgery 
Affiliation  Kasturba Medical College and Kasturba Hospital, Manipal  
Address  Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844409900  
Fax    
Email  stanley.mathew@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Badareesh L 
Designation  Professor of General Surgery 
Affiliation  Kasturba Medical College and Kasturba Hospital, Manipal  
Address  Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8861038876  
Fax    
Email  badareesh.l@manipal.edu  
 
Source of Monetary or Material Support  
Department of General Surgery, 3rd Floor, Smt.Sharadha Madhav Pai OPD Building, Kasturba Hospital, Kasturba Medical College, Manipal - 576104, Udupi District, Karnataka State, India  
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Dr.Padmaraj Hegde, Dean, First Floor, Administrative Building, Kasturba Medical College, Madhav Nagar, Manipal 576104, Udupi District, Karnataka State, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Stanley Mathew   Kasturba Hospital, Manipal  Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba Hospital, Manipal - 576 104
Udupi
KARNATAKA 
9844409900

stanley.mathew@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NA 
Comparator Agent  NIL  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1) Female patients between 18 to 80 years
2) Biopsy proven carcinoma breast
3) Patient undergoing Breast Conservative Surgery either upfront or after receiving chemotherapy  
 
ExclusionCriteria 
Details  1) Male breast carcinoma
2) Patients undergoing Modified Radical Mastectomy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Number of positive margins during the surgical procedure  10 days - till final histopathological report is available 
 
Secondary Outcome  
Outcome  TimePoints 
Number of revision surgical procedures due to positive margin  10 days - till final histopathological report is available 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   17/06/2024 
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 - 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
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response (Others) -  Any regulatory agency or editor/reviewer of a scientific publication

  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 (Others) -  Data will be provided based on a written request

  6. For how long will this data be available start date provided 31-08-2027 and end date provided 31-08-2032?
    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  

If Breast Conservation Surgery has been planned for the patient, she will be approached to obtain written informed consent on the day of her admission. Data associated with her pre operative evaluation will be collected from the medical records. On the day of the operation, the surgeon will perform the appropriate Breast Conservation Surgery. As part of the standard of care Wire Needle Localization, Specimen Mammography, Specimen Ultrasound and Frozen section (with painting of margins) may be performed. These are done to ensure that no tumour is remaining at the operated site. Data associated with these standard of care procedures will also be collected for this study. 

 
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