| 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
|
|
|
Primary Sponsor
|
| Name |
NIH Fogarty |
| Address |
Fogarty International Center
Bethesda Maryland 20892-2220, USA |
| Type of Sponsor |
Other [NIH Fogarty] |
|
|
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 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
|
|
|
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.
|