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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, |
|
Intervention / Comparator Agent
|
|
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. |