| CTRI Number |
CTRI/2024/08/072612 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Listing of all breast cancer patients less than 45 years of age at Balco Medical Centre. |
|
Scientific Title of Study
|
Registry on young women with breast cancer |
| 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 Bhawna Sirohi |
| Designation |
Senior Consultant |
| Affiliation |
BALCO medical Center |
| Address |
Room No. 4,Medical Oncology OPD, Ground Floor, B Wing, Balco Medical Centre,
Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh
Raipur
Raipur
CHHATTISGARH
493661
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhawna Sirohi |
| Designation |
Senior Consultant |
| Affiliation |
BALCO medical Center |
| Address |
Room No. 4,Medical Oncology OPD, Ground Floor, B Wing, Balco Medical Centre,
Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
493661
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhawna Sirohi |
| Designation |
Senior Consultant |
| Affiliation |
BALCO medical Center |
| Address |
Room No. 4,Medical Oncology OPD, Ground Floor, B Wing, Balco Medical Centre,
Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
493661
India |
| Phone |
9756999976 |
| Fax |
|
| Email |
bhawna.sirohi@vedanta.co.in |
|
|
Source of Monetary or Material Support
|
| BALCO Medical Center, Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh, India
493661
|
|
|
Primary Sponsor
|
| Name |
Vedanta Medical Research Foundation |
| Address |
Balco Medical Centre,
Sector 36, Atal Nagar, PO Uparwara, Raipur, Chhattisgarh, India 493661
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Bhawna Sirohi |
BALCO Medical Centre |
Room no 4, Medical Oncology,
Sector 36, Atal Nagar, PO:
Uparwara, Raipur, Chhattisgarh
493661
Raipur, CHHATTISGARH
Raipur
CHHATTISGARH |
9756999976
bhawna.sirohi@vedanta.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMC-IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
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 |
1. All Females who are under the age of 45 years old
2. Only Confirmed breast Cancer cases will be recruited |
|
| ExclusionCriteria |
| Details |
1. Male Individuals with breast cancer.
2. Female Individuals older than 45years
3.Female Individuals less than 18years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To describe the profile and patterns of breast Cancer patients availing of care at the reporting hospital.
|
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To contribute data on breast cancer patient to develop research capacity at BALCO medical Centre. |
24 Weeks |
|
|
Target Sample Size
|
Total Sample Size="50000"
Sample Size from India="50000"
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)
|
31/08/2024 |
| 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) |
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
|
Breast
cancer in young women is complex. Various aspects are poorly understood. There is a need for a
multi-centric registry to improve our understanding of aetiology, biology, treatment patterns and
outcomes in young women with breast cancer (YWBC).
Within this registry,
retrospective data collection will be conducted for YWBC diagnosed from March
2018 onwards till December 2024. Simultaneously, prospective data gathering for
new patients will be facilitated through a web-based software platform. To
ensure ethical standards, informed consent will be diligently obtained from new
or ongoing patients, granting permission for the retrieval of pertinent data
from their medical records. The decision regarding the requirement for formal
informed or data release consent, in accordance with institutional policies,
will be made at individual centres subsequent to approval from their respective
Ethics Committee, as applicable.
Eligible participants who
consent to participation will be assigned a unique identity number to uphold
confidentiality. The entry of patient data into the designated registry will
exclusively after obtaining informed consent. The registry will systematically
accumulate comprehensive data encompassing demographics, pertinent medical
history, administered treatments, occurrences of recurrence and disease
progression, details of the last follow-up, and current clinical status from
the medical records of YWBC.The clinical data collected is as mentioned in the
Case record form. For patients who have undergone prior treatment, relevant
data available in their medical records will be meticulously captured. |