| CTRI Number |
CTRI/2023/02/049872 [Registered on: 20/02/2023] Trial Registered Prospectively |
| Last Modified On: |
23/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
10-year survival of breast cancer patients in South India |
|
Scientific Title of Study
|
10-year overall survival of breast cancer patients in South India: A retrospective analysis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEHANNATHPARAMBIL KOTTARATHIL VIJAYKUMAR |
| Designation |
Professor and Head, Department of Surgical Oncology, Breast Diseases Division |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham
Ernakulam
KERALA
682041
India |
| Phone |
9744870684 |
| Fax |
|
| Email |
dkvijaykumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DEHANNATHPARAMBIL KOTTARATHIL VIJAYKUMAR |
| Designation |
Professor and Head, Department of Surgical Oncology, Breast Diseases Division |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham
Ernakulam
KERALA
682041
India |
| Phone |
9744870684 |
| Fax |
|
| Email |
dkvijaykumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhanya Mary Louis |
| Designation |
Research Assistant |
| Affiliation |
Amrita School of Pharmacy |
| Address |
Amrita School of Pharmacy,
Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham
Ernakulam
KERALA
682041
India |
| Phone |
7025347955 |
| Fax |
|
| Email |
dhanyamary303@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences, Kochi |
|
|
Primary Sponsor
|
| Name |
Amrita institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences, Amrita Vishwa Vidhyapeetham, AIMS-Ponekkara p.o, Kochi, Kerala, India pin: 682041
|
| 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 |
| DK Vijaykumar |
Amrita Institute of Medical Sciences |
Breast Diseases division, A Block, 3rd tower, Ground floor, Amrita Institute of Medical Sciences and Research Centre
Amrita Vishwa Vidyapeetham
Ernakulam
KERALA |
9744870684
dkvijaykumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Amrita Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C506||Malignant neoplasm of axillary tail of breast, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (4) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (5) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (6) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola, (7) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (8) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (9) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Breast cancer women who completed treatment from January 2011 to December 2021
Follow-up data available for a minimum duration of 1 year post completion of all treatment
Indian nationals
|
|
| ExclusionCriteria |
| Details |
Partial treatment taken elsewhere
Incomplete data
International patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| overall survival |
up to 10 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Demographic pattern and tumor characteristics |
10 years |
| factors affecting overall survival |
10 years |
|
|
Target Sample Size
|
Total Sample Size="10000"
Sample Size from India="10000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2023 |
| Date of Study Completion (India) |
30/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•We aim to assess the long-term survival outcome and factors affecting the quality of life in a cohort of breast cancer patients treated at AIMS Kochi over the last 10 years. |