| CTRI Number |
CTRI/2025/06/088939 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Developing a 3D Patient-Derived Brain Tumor Model to Track How Aggressive Breast Cancer Spreads to the Brain and to Discover New Targets for Precision therapy. |
|
Scientific Title of Study
|
Development of Multi-omics integrated patient-derived 3D-Brain Metastases organoid platform to understand evolutionary pathways of brain colonization from the primary Triple negative Breast cancer (TNBC) tumor and to identify clinically actionable targets for precision nano-biotherapeutics strategies innovation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 901126 Version 1.1 11/04/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tabassum Wadasadawala |
| Designation |
Professor, Department of Radiation Oncology |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Homi Bhabha Block,Room no. 1117,Department of Radiation Oncology,Dr E Borges Road, Parel (E) Mumbai, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02227405079 |
| Fax |
02227405061 |
| Email |
twadasadawala@actrec.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puja Sandbhor |
| Designation |
DST Inspire Faculty, PMRF-ANRF Department of Radiation Oncology |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
Paymaster Shodhika-Room no. 262, Department of Radiation oncology,Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, CISF Road, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
02227405127 |
| Fax |
|
| Email |
puja.sandbhor@actrec.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puja Sandbhor |
| Designation |
DST Inspire Faculty, PMRF-ANRF Department of Radiation Oncology |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
Paymaster Shodhika-Room no. 262, Department of Radiation oncology,Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, CISF Road, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
02227405127 |
| Fax |
|
| Email |
puja.sandbhor@actrec.gov.in |
|
|
Source of Monetary or Material Support
|
| Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, CISF Road, Kharghar, Navi Mumbai-410210 |
| Tata Memorial Hospital,Dr E Borges Road, Parel (E) Mumbai, India-400012
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tabassum Wadasadawala |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
Paymaster Shodhika -Room No 259,Department of Radiation oncology, Near Central Park, Sector 22, CISF Road,Kharghar, Navi Mumbai-410210
Raigarh
MAHARASHTRA |
02227405079
02227405061
twadasadawala@actrec.gov.in |
| Dr Tabassum Wadasadawala |
Tata Memorial Hospital |
Homi Bhabha Block,Room no. 1117,Department of Radiation Oncology,Dr E Borges Road, Parel (E), India-400012
Mumbai
MAHARASHTRA |
02227405079
02227405061
twadasadawala@actrec.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-III |
Approved |
| Institutional Ethics Committee-III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C793||Secondary malignant neoplasm of brain and cerebral meninges, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Triple Negative Breast Cancer Patients with brain metastasis |
|
| ExclusionCriteria |
| Details |
Patients not willing to sign the informed consent form (Prospective part of study)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study involves the development of patient-derived organoid models from clinical samples of individuals diagnosed with a specific subtype of breast cancer. The objective is to establish and characterize three-dimensional organoid systems derived from metastatic brain sites from primary breast tumor. The organoid platform will be leveraged to explore therapeutic sensitivities, with the broader goal of informing strategies for metastasis tumor growth from primary site. |
24 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary aims of this study include the evaluation of organoid responses to conventional therapeutic agents, with the goal of identifying treatment patterns that may correlate with clinical outcomes. The organoid system will further serve as a platform to evaluate the feasibility of targeted delivery strategies across the blood-brain barrier. |
36 months after surgery |
|
|
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)
|
01/08/2025 |
| 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="5"
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 aims to develop advanced laboratory models that replicate the progression of an aggressive form of breast cancer when it spreads to the brain. Such brain metastases are particularly difficult to diagnose and treat effectively, contributing to poor patient outcomes. By creating models derived from patient metastatic brain tumor samples, this research seeks to better understand how these cancers evolve and respond to treatment. The insights gained from this work may help identify why current therapies often fail and whether new treatment strategies can improve patient outcomes. Ultimately, the study hopes to contribute to the development of more effective interventions that could improve the survival and quality of life for patients facing this challenging disease. |