| CTRI Number |
CTRI/2024/01/061200 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
07/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Frailty screening instruments role in geriatric head neck cancer patients |
|
Scientific Title of Study
|
A prospective study to evaluate role of various frailty
screening instruments in predicting surgical complications in
geriatric head neck cancer patients. |
| 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 RAJEEV KUMAR |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS Delhi |
| Address |
DEPARTMENT OF ENT
AIIMS DELHI
ANSARI NAGAR
NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9968569892 |
| Fax |
|
| Email |
rajeev9843@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Kumar |
| Designation |
Senior Resident ACADEMICS |
| Affiliation |
AIIMS Delhi |
| Address |
Department of ENT
AIIMS Delhi
Ansari Nagar
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9855226820 |
| Fax |
|
| Email |
dramit4111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Kumar |
| Designation |
Senior Resident ACADEMICS |
| Affiliation |
AIIMS Delhi |
| Address |
Department OF ENT
AIIMS Delhi
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9855226820 |
| Fax |
|
| Email |
dramit4111@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES
ANSARI NAGAR
NEW DELHI
110029 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
ANSARI NAGAR
NEW DELHI
110029
INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 RAJEEV KUMAR |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ENT
ALL INDIA INSTITUE OF MEDICAL SCIENCES
ANSARI NAGAR
NEW DELHI
110029
INDIA
New Delhi
DELHI |
9968569892
rajeev9843@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee For Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients age 60 years and above with the diagnosis of head neck malignancy who are
undergoing surgery with the curative intent will be included for the surgery |
|
| ExclusionCriteria |
| Details |
Recurrent Head neck cancers undergoing surgery.
Patients who received adjuvant treatment before surgery will not be included |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome measure will be surgical complications which will be classified according to classification system given by Clavien-Dindo. |
At the time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Combined predictive value of two or more frailty screening instruments in predicting surgical complication. |
At the time of data analysis |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
15/01/2024 |
| 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="2"
Months="0"
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
|
There is a lack of consensus regarding the most appropriate frailty screening instrument in head-neck oncology practice. On review of the literature, most studies were retrospective in nature. No study in our review shows the combined predictive value of two or more frailty screening instruments. All the literature is related to the western population, and we could not identify any study that identifies the risk stratification of frailty in the context of head and neck oncology patients in India or South East Asian countries.
This study aims to assess the role of various frailty screening instruments in predicting surgical complications in geriatric head neck cancer patients.| Identifying frailty and its outcome can help healthcare providers in decision making, prognostication, better resource utilizations and planning individualized patient care. |
|