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CTRI Number  CTRI/2025/03/083696 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 26/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Cosmetic Outcomes and Quality of Life in patients undergoing Breast Conservation surgery for Breast Cancer. 
Scientific Title of Study   Cosmetic Outcomes and Quality of Life in patients undergoing Breast Conservation Surgeryfor Carcinoma Breast- An Ambispective Observational study 
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 Chandralal PG 
Designation  Senior Resident 
Affiliation  Department of Surgical Oncology,AIIMS Jodhpur 
Address  Room No 3132 , Nedical College building , Department Of Surgical Oncology AIIMS Jodhpur , Basni phase 2 , Jodhpur ,Rajasthan 342005 India
AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India 
Phone  9446908629  
Fax    
Email  chandralalpg1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nivedita Sharma 
Designation  Associate Professor 
Affiliation  Department of Surgical Oncology,AIIMS Jodhpur 
Address  Room No 3132 , Medical College building , Department Of Surgical Oncology AIIMS Jodhpur , Basni phase 2 , Jodhpur ,Rajasthan 342005 India
AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India 
Phone  7034635141  
Fax    
Email  nivsha1985@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chandralal PG 
Designation  Senior Resident 
Affiliation  Department of Surgical Oncology,AIIMS Jodhpur 
Address  Room No 3132 , Nedical College building , Department Of Surgical Oncology AIIMS Jodhpur , Basni phase 2 , Jodhpur ,Rajasthan 342005 India
AIIMS Jodhpur

RAJASTHAN
342005
India 
Phone  9446908629  
Fax    
Email  chandralalpg1@gmail.com  
 
Source of Monetary or Material Support  
AIMMS -Jodhpur,Basni Phase II Industrial Area,Jodhpur,Rajasthan 342005 
 
Primary Sponsor  
Name  Dr Chandralal PG  
Address  OPD Room no 5069, 5th floor , A Block,Department of Surgical Oncology , AIIIMS Jodhpur 
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 Chandralal PG  All India Institute of Medical Sciences  OPD no 509 , 5th floor A block, Department of Surgical Oncology,AIIMS Jodhpur,Basni Phase II 342005,Rajasthan India.
Jodhpur
RAJASTHAN 		 9446908629

chandralalpg1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee(Clinical trial),AIIMS Jodhpur  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 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1) All biopsy proven breast cancer patients with stage (cT1-3 N1-2 M0) who will undergo/ underwent breast conservation surgery upfront or post neoadjuvant chemotherapy. 
 
ExclusionCriteria 
Details  1)Previous history of mastectomy on contralateral side.
2)Present history of bilateral carcinoma breast warranting mastectomy on one side.
3)Not giving informed consent.
4)Incomplete medical records (for retrospective patients)
5)Patients who are unable to read or understand English/Hindi for completing the quality of life (QOL) questionnaire, as well as those with psychiatric illnesses that may interfere with subjective assessment of cosmesis and QOL
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the cosmetic outcome in breast cancer patients undergoing/undergone Breast Conservation (BCS) surgery using objective assessment tool - BCCT.core software.  To assess the cosmetic outcome in breast cancer patients undergoing/undergone Breast Conservation (BCS) surgery using objective assessment tool - BCCT.core softwareat 4 weeks and 6 months . 
 
Secondary Outcome  
Outcome  TimePoints 
1. To analyze various clinical and surgical factors to determine the key factors affecting cosmetic outcomes in patients undergoing breast conservation surgery.
2. To compare cosmetic outcomes among patients undergoing breast conservation (BCS) with conventional closure, BCS with volume displacement oncoplasty and BCS with volume replacement oncoplasty
3. To assess patient satisfaction with cosmesis and its correlation with objective cosmetic outcome.
4. To evaluate the quality of life among patients undergoing breast conservation surgery and its correlation with objective cosmetic outcome.
5. To analyze the incidence and impact of post-operative complications on cosmetic outcomes and quality of life in patients undergoing BCS.
 		 1 month and 6 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   06/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  06/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="7"
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 -  Statistical Analysis Plan
    Response - Clinical Study Report

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [chandralalpg1@gmail.com].

  6. For how long will this data be available start date provided 01-06-2027 and end date provided 01-06-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

•        This is an ambispective observational study on cosmetic outcomes and quality of life in patients undergoing breast conservational surgery for Carcinoma Breast under the Department of Surgical Oncology. Total 51 patients of breast cancer underwent Breast Conservation Surgery between January-December 2023. Thus we aim to include minimum 120 patients (50 patients prospectively and 70 patients retrospectively) during the study period. Patients are included in study based on fixed inclusion criteria. Primary objectives of the study is to assess the cosmetic outcome and quality of life of the patients undergoing BCS and secondary outcomes are complications associated with the procedure and other associated factors. Data will be collected both prospectively and retrospectively from inpatients and medical records respectively. For cosmetic outcomes, BCCT core and to assess quality of life, BREAST Q questionnaire will be used.

 
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