| CTRI Number |
CTRI/2025/05/087507 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Cancer in the Elderly: Geriatric and oncology assessment |
|
Scientific Title of Study
|
Understanding Cancer in the Elderly: A combined Retrospective and Prospective Analysis from the Geriatric Oncology Clinic at AIIMS, New Delhi |
| 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 NIDHI SONI |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi India |
| Address |
Department of Geriatric Medicine, room number 607, Sixth floor
NCA (National center for ageing), AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
08527118534 |
| Fax |
|
| Email |
nidhisoni1962@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NIDHI SONI |
| Designation |
assistant professor |
| Affiliation |
AIIMS, New Delhi India |
| Address |
Department of Geriatric Medicine, room number 607, Sixth floor
NCA (National center for ageing), AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
08527118534 |
| Fax |
|
| Email |
nidhisoni1962@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NIDHI SONI |
| Designation |
assistant professor |
| Affiliation |
AIIMS, New Delhi India |
| Address |
Department of Geriatric Medicine, room number 607, Sixth floor
NCA (National center for ageing), AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
08527118534 |
| Fax |
|
| Email |
nidhisoni1962@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Geriatric Medicine, NCA, AIIMS, Ansari Nagar, New Delhi |
|
|
Primary Sponsor
|
| Name |
Reseach section AIIMS |
| Address |
Ansari Nagar, New Delhi, 110029 |
| 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 Nidhi soni |
AIIMS |
NCA, Ansari Nagar, New Delhi
South
DELHI |
08527118534
nidhisoni1962@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, New Delhi India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NIl |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All treatment naïve patients with diagnosis of malignancy
2. ECOG performance status 0 to 3
|
|
| ExclusionCriteria |
| Details |
1. Patients requiring radiotherapy intervention
2. Patients/ caregivers refuse for geriatric assessment
3. Patients refuse to give written informed consent
4. Patients having major neurological or medical disorder that impairs their ability to understand the study and give written informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| geriatric vulnerabilities |
at 3 months, 6 months and 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life of patients |
at baseline, 3 months and 6 months |
| Chemotherapy toxicity risk assessment |
3 and 6 months |
| caregiver burden |
at baseline |
| non-cancer life expectancy |
baseline |
| oncology related parameters: types of malignancy, staging, treatment planned |
at baseline |
| treatment abandonment, lost to follow up, overall survival, and disease-free survival in these patients |
3 months, 6 months and 1 year |
| correlation of different geriatric conditions, clinical parameters, laboratory parameters with different outcomes (chemotherapy toxicity, overall survival, and quality of life) of the patients |
3, 6 and 12 months |
| impact of different individualized interventions (geriatric-assessment based, change in medical management) on different outcomes (chemotherapy toxicity, overall survival, and quality of life, patients and caregiver satisfaction) |
3,6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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)
|
05/06/2025 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Indian population is aging with increased percentage of older age population. This further increases the prevalence of chronic, non-communicable diseases, of which malignancies are one. Two important aims of treatment in older patients with cancer are increasing survival and improving their health-related quality of life (HRQoL). The management of older cancer population is challenging in view of increased number of comorbidities and increased age-related issues, which can be assessed by comprehensive geriatric assessment. Some fit older patients are denied active intervention, despite their tumor being amenable to radical treatment, because of fear of excessive morbidity (6) and sometimes even frail older patients undergo aggressive therapy leading to toxicity, morbidity and mortality (7). Striking right balance is the key, but it is challenging. Geriatric medicine department in AIIMS has a high flow of patients, and most of the patients are diagnosed with malignancies during evaluation, and sending them to medical oncology department leads to loss to follow up from geriatric department and sometimes break in line of care. Hence, geriatric oncology clinic has been started in National Centre of Ageing, in collaboration with medical oncology team from IRCH. The main aim of geriatric oncology clinic is to provide comprehensive care under one roof and improve the outcome of the patients |