| CTRI Number |
CTRI/2025/09/094348 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Real time genome analysis to personalise breast cancer treatment |
|
Scientific Title of Study
|
Personalised Breast Cancer Program- India (PBCP-I) |
| Trial Acronym |
PBCP-I |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjoy Chatterjee |
| Designation |
Senior Consultant Department of Radiation Oncology Tata Medical Center, Kolkata |
| Affiliation |
Tata Medical Centre, Kolkata |
| Address |
Department of Radiation Oncology, Tata Medical Centre, Newtown, Kolkata
Kolkata
WEST BENGAL
700160
India
Kolkata WEST BENGAL 700160 India |
| Phone |
9038161825 |
| Fax |
|
| Email |
sanjoy.chatterjee@tmckolkata.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjoy Chatterjee |
| Designation |
Senior Consultant Department of Radiation Oncology Tata Medical Center, Kolkata |
| Affiliation |
Tata Medical Centre, Kolkata |
| Address |
Department of Radiation Oncology, Tata Medical Centre, Newtown, Kolkata
Kolkata
WEST BENGAL
700160
India
Kolkata WEST BENGAL 700160 India |
| Phone |
9038161825 |
| Fax |
|
| Email |
sanjoy.chatterjee@tmckolkata.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanjoy Chatterjee |
| Designation |
Senior Consultant Department of Radiation Oncology Tata Medical Center, Kolkata |
| Affiliation |
Tata Medical Centre, Kolkata |
| Address |
Department of Radiation Oncology, Tata Medical Centre, Newtown, Kolkata
Kolkata
WEST BENGAL
700160
India
Kolkata WEST BENGAL 700160 India |
| Phone |
9038161825 |
| Fax |
|
| Email |
sanjoy.chatterjee@tmckolkata.com |
|
|
Source of Monetary or Material Support
|
| Blockchain for Impact(BFI)
Queens Tower, Delflandlaan 1, 1062 EA Amsterdam, the Netherlands
Mr. Sandeep Nailwal, Chairman
sandeep@blockchainforimpact.nl
9819989954
|
|
|
Primary Sponsor
|
| Name |
Tata Medical Center |
| Address |
14 MAR (E-W), New Town, Rajarhat, Kolkata 700 160, West Bengal, India. |
| 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 Sanjoy Chatterjee |
Department of Radiation Oncology, Tata Medical Centre |
14 MAR (E-W), New Town, Rajarhat, Kolkata 700 160, West Bengal, India. Kolkata WEST BENGAL |
9038161825
chatterjee72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TATA MEDICAL CENTER - INSTITUTIONAL REVIEW BOARD |
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 |
To be included in the trial the patient must:
1.Have given written informed consent to participate for the study according to national/local regulations
2. Be aged over 18 years’ old
3. ECOG performance status 0, 1 or 2
4. Patient with histological diagnosis of AJCC Stage 1, 2, 3 or 4 invasive breast cancer (the presence of high grade DCIS is acceptable), including new loco-regional relapse or new metastatic lesion.
5. Patients scheduled for a biopsy/surgical procedure of the new lesion or fresh tissue available for research
|
|
| ExclusionCriteria |
| Details |
Presence of any psychological, family, sociological or geographic condition potentially hampering compliance with the study protocol and follow-up schedule. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Main outcome:
Proportion of patients that receive personalised treatment based on genomic results.
|
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the impact of genome-driven personalised medicine on breast cancer outcomes at 3 years in a non-selective, real-world setting.
2.To assess the effect of a genomic profiling programme on the identification of patients for clinical trials inclusion in a breast cancer population of all stages of disease.
3.To describe the influence of WGS on categories of clinical management: surgery; referral to clinical genetics; genomic-directed therapy change; genomic-directed toxicity management change; genomic-guided recommendation for future therapy.
4.To characterise molecular profiles or mutation signatures of breast cancer patients (both tumour and germline) with subsequent stratification of patients, and correlation of these profiles with clinical outcomes.
4.To ascertain the TME on tissue blocks and study its associations to the various molecular subtypes
|
5 years |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
01/12/2025 |
| 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 Yet Recruiting |
| 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
|
Patients recruited to this Pilot study will have the whole genome of the tumor and cells sequenced and data stored in database. Treatment, demographic and clinical outcomes data will be collected and then clinical outcomes followed up for a minimum of 3 years (or until death) and correlated with the molecular profiles generated. The whole genome sequencing (WGS) data generated will allow classification into both prognostic risk groups and also potentially identify molecular drivers of breast cancer (e.g. CCND1, PAK1, ERBB2) and molecular profiles predictive of treatment response or non-response. We will store the RNA during the lifetime of the study from the patients where genome is sequenced, and we will explore the feasibility of including these results in clinical reports at a later stage. We will also investigate mutation signatures associated with prediction of treatment response to chemotherapy and also targeted agents. This will be a single-centre study in Tata Medical Center, Kolkata with a sample size of 200 patients with breast cancer. Patients will be followed-up for a minimum of 5 years (or until death) from the date they receive their genomic results. The primary objective is to evaluate the clinical feasibility and clinical utility of Whole Genome Sequencing (WGS) in the clinical management of breast cancer patient, in real world setting |