| CTRI Number |
CTRI/2021/07/034792 [Registered on: 12/07/2021] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of geriatric assessment tools on 1- year mortality in non-metastatic breast cancer patients 65 years and older |
|
Scientific Title of Study
|
PROspecTive Study on the use of gEriatriC assessment Tools for validation of 1- year mortality in non-metastatic breast cancer patients 65 years and older |
| Trial Acronym |
PROTECT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tabassum Wadasadawala |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Department of Radiation Oncology, Tata memorial Hospital, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
91-22-24177026 |
| Fax |
|
| Email |
twadasadawala@actrec.gov.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tabassum Wadasadawala |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Department of Radiation Oncology, Tata memorial Hospital, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
91-22-24177026 |
| Fax |
|
| Email |
twadasadawala@actrec.gov.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivani Sable |
| Designation |
Junior Resident 2 |
| Affiliation |
Tata Memorial Hospital, Mumbai |
| Address |
Department of Radiation Oncology, Tata memorial Hospital, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
09561096710 |
| Fax |
|
| Email |
shivanisable.44@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Center |
| Address |
Tata Memorial Centre, Dr Ernest Borges Home, Parel, Mumbai |
| 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 Tabassum Wadasadawala |
Tata Memorial Centre |
Department of Radiation oncology, Homi Bhabha building room 105/108, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai Mumbai MAHARASHTRA |
2224177000-6116
twadasadawala@actrec.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-I |
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
|
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
a study of geriatric breast cancer patients |
|
| ExclusionCriteria |
| Details |
1. Not willing to participate
2. Unable to understand the questionnaires |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cumulative incidence of 1 year mortality. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Validation of MPI and Onco-MPI for 1-year mortality.
2. Comparison of outcome using MPI and Onco-MPI with conventional prognostic factors.
3. To study quality-of-life using the WHO BREF questionnaire pre- and post-treatment.
4. To study the impact of cancer treatment on the systemic organ functions pre-and post-treatment.
5. Sensitivity of G8 and VES-13 as screening tools for geriatric assessment
6. 2-year mortality
|
2 year |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
15/07/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The proposed study focuses on assessing the older patients (>/= 65 years) by using three geriatric scales. The aim of the study is to detect various problems faced by the older patients undergoing treatment for breast cancer. These include health related, social, psychological and economic problems. The four scales which will be used are Multidimensional prognostic index and Onco-multidimensional prognostic index, both of which involves a detailed assessment, VES-13 and G8 which are shorter tools. This assessment will be carried out at the beginning of the cancer directed treatment so that we can understand how treatment decisions (and subsequent survival) are affected by various factors in elderly patients. The quality of life will also be assessed using WHO-BREF questionnaire, which will be given at the time of initial assessment, after the completion of treatment and also during follow up every 6 months till 2 years. The survival outcome and quality of life will be studied in relation to the geriatric scales data. Moreover, the usefulness of the short tools (G8 and VES-13) will be studied with respect to the longer MPI & onco-MPI tool to understand feasibility for routine clinical use. The study will be conducted over a 4-year period, 2 years for accrual of 300 patients and 2 years for follow up. |