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CTRI Number  CTRI/2025/08/093566 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Studying Tumor Surroundings to Improve Postpartum Breast Cancer Care 
Scientific Title of Study   Spatial Profiling of Tumor Micro-environment in Postpartum Breast Cancer Implications for Prognosis and Targeted Therapies 
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 Vidya P Nimbalkar 
Designation  Project Research Scientist 
Affiliation  St Johns Research Institute Bengaluru 
Address  Division of Molecular Medicine, Nadathur Breast cancer lab, 1st floor Academic block, Koramangala, Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  08049467142  
Fax    
Email  vidya.pn@sjri.res.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vidya P Nimbalkar 
Designation  Project Research Scientist 
Affiliation  St Johns Research Institute Bengaluru 
Address  Division of Molecular Medicine, Nadathur Breast cancer lab, 1st floor Academic block, Koramangala, Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  08049467142  
Fax    
Email  vidya.pn@sjri.res.in  
 
Details of Contact Person
Public Query
 
Name  Dr Jyothi S Prabhu 
Designation  Head and Professor 
Affiliation  St Johns Research Institute Bengaluru 
Address  Division of Molecular Medicine, Nadathur Breast cancer lab, 1st floor Academic block, Koramangala, Bengaluru.

Bangalore
KARNATAKA
560034
India 
Phone  08049467141  
Fax    
Email  jyothi@sjri.res.in  
 
Source of Monetary or Material Support  
NIH Fogarty 
 
Primary Sponsor  
Name  NIH Fogarty 
Address  Fogarty International Center Bethesda Maryland 20892-2220, USA 
Type of Sponsor  Other [NIH Fogarty] 
 
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 Vidya P Nimbalkar  St Johns Research Institute  Division of Molecular Medicine, Nadathur Breast cancer lab, 1st floor Academic block, Koramangala, Bangalore
Bangalore
KARNATAKA 
08049467142

vidya.pn@sjri.res.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, St John’s Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Tumor samples obtained from a previously collected breast cancer tissue cohort in the laboratory. Primary treatment naïve Breast Cancer patients under 45 years with information on childbirth, clinicopathological features and follow up on disease outcome will be included. 
 
ExclusionCriteria 
Details  NACT Neo adjuvant chemotheraphy, Missing childbirth information, Patients above 45 years  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Identification of distinct spatial gene expression patterns and immune/stromal signatures in postpartum breast cancer (PPBC) tumors using spatial profiling that are associated with poor clinical outcomes (e.g., recurrence, metastasis, or reduced overall survival).  The duration of the primary Outcome will be Nine Months.
Total Study Duration twelve Months. 
 
Secondary Outcome  
Outcome  TimePoints 
Validation of key biomarkers using multiplex immunohistochemistry mIHC Comparison of tumor microenvironment between PPBC post partum breast cancer and nonPPBC patients
Evaluation of biomarkers prognostic value for identifying high risk PPBC patients
 
Three Months after primary Outcome 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   10/09/2025 
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="1"
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 - NO
Brief Summary  
This study (retrospective observational/experimental study) will be conducted in St. John’s Research Institute, Bangalore, India under the LMIC mentor Dr. Jyothi S Prabhu, Faculty, Division of Molecular medicine, St. John’s Research Institute.This project aims to investigate the unique tumor micro-environment (TME) of postpartum breast cancer (PPBC) samples already collected from women under 45 years of age using archived FFPE (formalin fixed paraffin embedded) tissue and clinical data. Treatment-naïve primary tumor samples will be selected from an existing breast cancer cohort. Spatial profiling will be performed to characterize immune and stromal cell distribution within the TME. Clinical, reproductive, and pathological data will be integrated to identify PPBC-specific features. Key biomarkers identified through spatial profiling will be validated using multiplex immuno-histochemistry (mIHC). Comparative analysis will be conducted between PPBC and non-PPBC cases to uncover differentially enriched immune pathways or cell types. Long-term follow-up data will be used to assess the prognostic significance of these biomarkers in stratifying high-risk patients. Only de-identified data will be securely shared with the U.S. mentor as part of this NIH Fogarty INSIGHT Fellowship. The study adheres strictly to ethical guidelines and poses minimal risk to participants as it is retrospective study performed only on the already collected tissue samples.

Samples for this study have been collected from a breast cancer patient cohort referenced in these publications: 

Nimbalkar VP, Snijesh VP, Rajarajan S, Anupama CE, Mahalakshmi S, Alexander A, Dechamma D, Moorthy M, Ramaswamy G, Ramesh R, Srinath BS, Prabhu JS. Spatial profiling reveals unique immune microenvironment in premenopausal triple-negative breast cancer associated with therapy response. J Transl Med. 2025 Jul 10;23(1):761. doi: 10.1186/s12967-025-06786-8. PMID: 40640880; PMCID: PMC12243298.

Nimbalkar VP, Snijesh VP, Rajarajan S, Alexander A, Kaluve R, Ramesh R, Srinath BS, Prabhu JS. Premenopausal women with breast cancer in the early post-partum period show molecular profiles of invasion and are associated with poor prognosis. Breast Cancer Res Treat. 2023 Jul;200(1):139-149. doi: 10.1007/s10549-023-06956-6. Epub 2023 May 9. PMID: 37160509; PMCID: PMC10224850.




 
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