| CTRI Number |
CTRI/2025/07/091416 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound, Immunology and Genomics for Understanding Therapy Response in Breast Cancer |
|
Scientific Title of Study
|
Measuring the Response to Neo-Adjuvant Chemotherapy for Breast Cancer using Novel Ultrasound Device and Quantitative Multi-Omics Data - A pilot 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 S Annapurna |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Bibinagar |
| Address |
Department of Radiodiagnosis, All India Institute of Medical Sciences Bibinagar, Hyderabad
Hyderabad
TELANGANA
508126
India |
| Phone |
8685293300 |
| Fax |
|
| Email |
purnasrirambhat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash Eranki |
| Designation |
Assistant Professor |
| Affiliation |
IIT Hyderabad |
| Address |
Medical Ultrasound Research Laboratory, Department of Biomedical Engineering, Indian Institute of Technology Hyderabad, Kandi
Hyderabad
TELANGANA
502285
India |
| Phone |
04023016110 |
| Fax |
|
| Email |
aeranki@bme.iith.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avinash Eranki |
| Designation |
Assistant Professor |
| Affiliation |
IIT Hyderabad |
| Address |
Medical Ultrasound Research Laboratory, Department of Biomedical Engineering, Indian Institute of Technology Hyderabad, Kandi
TELANGANA
502285
India |
| Phone |
04023016110 |
| Fax |
|
| Email |
aeranki@bme.iith.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Institute of Technology Hyderabad, Kandi, Sangareddy, Telangana, India - 502284 |
|
|
Primary Sponsor
|
| Name |
Indian Institute of Technology Hyderabad |
| Address |
Indian Institute of Technology Hyderabad, Kandi, TG - 502285 |
| Type of Sponsor |
Research institution |
|
|
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 S Annapurna |
All India Institute of Medical Sciences Bibinagar |
AIIMS BBN (Hyderabad Metropolitan Region), Bibinagar, Dist.Yadadari Bhuvanagiri, Telangana, India -508126
Hyderabad
TELANGANA |
8685293300
purnasrirambhat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS BBN-IEC |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Locally advanced breast cancer (TNM stage greater than or equal to T1c or patients satisfying the clinical criteria for neoadjuvant chemotherapy) |
|
| ExclusionCriteria |
| Details |
1. Recurrent disease
2. Metastatic disease
3. Unable to tolerate chemotherapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is the ability to understand the relationship between tumor morphology, immune infiltration, and genetic variations. |
These will be assessed at the baseline, 4 weeks post-neo-adjuvant chemotherapy, and 8 weeks post-neo-adjuvant chemotherapy.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
01/09/2025 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The tumor microenvironment
in breast cancer varies within the tumor and amongst the various tumor subtypes, accounting for the heterogeneity of breast cancers. The initiation and
progression of breast tumors rely heavily on the interface between the breast
tumor and its surrounding, otherwise considered healthy parenchyma. The
peritumor is functionally and phenotypically dissimilar from the intra-tumor
and the healthy parenchyma and is known to vary spatially around the tumor
boundary. The tumor and peritumor interactions could suggest tumor evolution
and invasion, potentially influencing cellular migration and proliferation in
malignant breast tumors. This interaction could also provide some insight into the
response to NACT, and subsequently developing strategies to improve therapeutic
response.
Objectives:
1. Map and quantify the tumor microvasculature of breast
tumors in 3D using ultrasound imaging and correlate with 3D shearwave (SWE) elastography
and 3D ultrasound texture before, during, and post-NACT.
2. Measure the expression of adhesion molecules, tumor-infiltrating lymphocytes, tumor-associated macrophages, and fibroblasts intra-
and peri-tumorally before, during, and post-NACT.
3. Quantify the expression of genes in the tumor and circulating
blood using whole-exome/genome sequencing and correlate against imaging and
immune readouts before, during, and post-NACT. |