| CTRI Number |
CTRI/2026/02/102901 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Comprehensive Geriatric Assessment of elderly patients with cancers |
|
Scientific Title of Study
|
Comprehensive Geriatric Assessment of elderly patients with cancers-A Prospective Observational Study |
| 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 ABHISEK PAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SCHOOL OF PHARMACEUTICAL SCIENCES |
| Address |
Department of Pharmacology, Schlool Of Pharmaceutical Sciences, K-8, KALINGA NAGAR, BHUBANESWAR, ODISHA,751003
Khordha
ORISSA
751003
India |
| Phone |
9437835969 |
| Fax |
|
| Email |
abhisek.cology@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SOUMYA SURATH PANDA |
| Designation |
PROFESSOR |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
Department of Medical Oncology, IMS & SUM HOspital, K-8, KALINGA NAGAR, BHBANESWAR, ODISHA
Khordha
ORISSA
751003
India |
| Phone |
8895370579 |
| Fax |
|
| Email |
ssp_scb@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
PRATISHYA BHATTA |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
SCHOOL OF PHARMACEUTICAL SCIENCES |
| Address |
Department of Medical Oncology, School of Pharmaceutical Sciences, K-8, KALINGA NAGAR, BHBANESWAR, ODISHA
Khordha
ORISSA
751003
India |
| Phone |
7978210565 |
| Fax |
|
| Email |
pratishabhatta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IMS AND SUM HOSPITAL |
| Address |
Department of Medical Sciences, IMS and SUM Hospital, K-8, KALINGA NAGAR, BHUBANESWAR, ODISHA, INDIA, 751003 |
| Type of Sponsor |
Private 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 Soumya Surath Panda |
IMS AND SUM HOSPITAL |
IMS and SUM Hospital, K-8, KALINGA NAGAR, BHBANESWAR, ODISHA, INDIA, 751003
Khordha
ORISSA |
08895370579
ssp_scb@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: Z739||Problem related to life managementdifficulty, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age above greater than 65.
ECOG status less than 4.
Diagnosis (Radiological or Histopathological) of Lung, breast, prostate, or colon cancer.
Oncological treatment (chemotherapy, radiation, and surgery) is planned. |
|
| ExclusionCriteria |
| Details |
1 Patients who decline to provide their consent.
2 Patients who are terminally ill.
3 Psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the patients functional condition.
To observe the cognitive status of the patient.
To observe the patients psychological condition.
|
The outcome will be assessed/estimated i.e., at baseline,3, 6, and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
20/02/2026 |
| 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
|
With the global
increase in life expectancy, the incidence of cancer in the elderly population
is rising steadily. It is estimated that more than 60% of all cancers occur in
individuals aged 65 years and older. However, this population is often
underrepresented in clinical trials, and treatment decisions are frequently
based on chronological age rather than their physiological reserve or
functional status. |