| CTRI Number |
CTRI/2024/12/078535 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
22/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
RETROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
Study from a tertiary cancer center assessing the 100 day death rate in solid cancer patients, post systemic therapy. |
|
Scientific Title of Study
|
100 Day Mortality In Advanced Solid Malignancies- Real World Experience In A Tertiary Cancer Centre From South India. |
| 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 SHASHIDHAR V K |
| Designation |
head of dept and professor |
| Affiliation |
VYDEHI INSTITUTE OF MEDICAL SCIENCES & RESEARCH CENTER |
| Address |
Department of medical oncology, ground floor, room 3, vydehi institute of medical sciences and research institute
white field bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
8861085629 |
| Fax |
|
| Email |
shashivk5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHUBHA SUPRIYA A |
| Designation |
SENIOR RESIDENT |
| Affiliation |
560066 |
| Address |
Department of medical oncology,ground floor, room 3,vydehi institute of medical sciences and research institute
white field bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
9148916220 |
| Fax |
|
| Email |
shubha30891@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHUBHA SUPRIYA A |
| Designation |
SENIOR RESIDENT |
| Affiliation |
560066 |
| Address |
department of medical oncology, groud floor, room 3, vydehi institute of medical sciences and research institute
white field bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
9148916220 |
| Fax |
|
| Email |
shubha30891@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NON SPONSOR STUDY] |
|
|
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 |
| SHUBHA SUPRIYA A |
VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH INSTITUTE |
department of medical oncology, ground floor, room 3,Vydehi Institute of Medical Sciences and Research centre
EPIP Area Whitefield Bengaluru Karnataka India 560066
Bangalore
KARNATAKA |
9148916220
shubha30891@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VYDEHI INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SYSTEMIC THERAPY |
CHEMOTHERAPY / IMMUNOTHERPY / TARGETED THERAPY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Performance status 1-3 ECOG
Age > 18 years
Solid cancers
Stage IV
Planned for palliative sytemic treatment
|
|
| ExclusionCriteria |
| Details |
 Patient not eligible and not willing for systemic therapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO DETERMINE THE 100 DAY MORTALITY |
MORTALITY STATUS ON DAY 100 FROM THE START OF FIRST CYCLE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO STUDY FACTORS AFFECTING 100 DAY MORTALITY |
DATA COLLECTED BEFORE THE START OF TREATMENT LIKE AGE, NLR, PS, HEMOGLOBIN, ALBUMIN |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
15/01/2025 |
| 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="0"
Months="6"
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
|
AIM-To determine the 100 day mortality in palliative intent patients? And what are the prognostic factors affecting it?
-Key findings Hundred day mortality was 16%. In this study subgroup analysis showed neutrophil lymphocyte ratio (p=0.04) and performance status (p=0.02) are the significant factors associated 100 day mortality. -Impact. Assessing the 100 day mortality validates the clinical decision taken in a department / an institute. Based on this necessary action can be taken to improve the outcome and quality of care.
|