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CTRI Number  CTRI/2021/09/036703 [Registered on: 21/09/2021] Trial Registered Prospectively
Last Modified On: 10/09/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Study of proteomics in blood of women with breast cancer  
Scientific Title of Study   Clinical significance of Proteomics in liquid biopsy for Indian breast cancer women: An Exploratory study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suhani 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Surgical Disciplines, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi

South
DELHI
110029
India 
Phone  9810534358  
Fax    
Email  drsuhani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Suhani 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Surgical Disciplines, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi


DELHI
110029
India 
Phone  9810534358  
Fax    
Email  drsuhani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Suhani 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Surgical Disciplines, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi


DELHI
110029
India 
Phone  9810534358  
Fax    
Email  drsuhani@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Ansari Nagar East New Delhi 
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 Suhani  All India Institute of Medical Sciences New Delhi  Department of Surgical Disciplines, Surgery office CMET, Ansari Nagar East
South
DELHI 
01126594560

drsuhani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS New Delhi  Submittted/Under Review 
Institute ethics committee AIIMS New Delhi  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Treatment naïve biopsy proven breast cancer women
Patients giving consent to participate in the study
 
 
ExclusionCriteria 
Details  pregnant and lactating women  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
study of Differential proteomics in treatment naïve breast cancer women
 
Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
Differential proteomics after Neo-adjuvant chemotherapy in patients receiving the same  10-14 weeks from baseline 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/10/2021 
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="3"
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 - NO
Brief Summary  

Breast cancer is the most frequent cancer among women in the world with an estimated 2.08 million new cancer cases diagnosed in 2018, which is much higher than the 1.67 million new cases diagnosed in 2012, constituting about 25% of all cancers. The available Indian literature and our clinical experience suggest that the age at presentation, risk factors, outcome and behavior of most of our breast cancer patients differ from those reported in the west. There is paucity of published literature on the risk factors and biomarkers for breast cancers in the Indian setting. The available literature focusses on the clinical and epidemiological factors study. An understanding of the underlying biological mechanisms of carcinogenesis and the altered molecular events in breast cancer can be studied with help of differential proteomics. Genes work at the protein level, and comparisons of transcript and corresponding protein expression have shown that mRNA and protein levels are not necessarily highly correlative. Since almost all therapeutic intervention strategies involve targeting and modulating protein function and activity, it is imperative that proteomics forms a central analyses of mechanism underlying tumorigenesis in breast cancer. Keeping the differences in disease presentation and aggressive behaviour in Indian women, we wish to study the differential proteomics in our patients. The collaborative work in studying the proteomics in liquid biopsy in breast cancer patients may help us to plan further studies which may give an insight into the etiological differences. Furthermore, differentially expressed protein pathways in such women may help identify potential therapeutic targets. 

 

 
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