| CTRI Number |
CTRI/2024/09/073208 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Patient survey |
| Study Design |
Other |
|
Public Title of Study
|
A patient survey on liver cancer surveillance practices in India |
|
Scientific Title of Study
|
Anonymized patient survey on hepatocellular carcinoma (HCC) surveillance practices in 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 Prachi Patil |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department Of Digestive Disease and Clinical Nutrition
Tata Memorial Hospital
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
912224177000 |
| Fax |
|
| Email |
prachipatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prachi Patil |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department Of Digestive Disease and Clinical Nutrition
Tata Memorial Hospital
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
912224177000 |
| Fax |
|
| Email |
prachipatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Patil |
| Designation |
Professor and Head |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department Of Digestive Disease and Clinical Nutrition
Tata Memorial Hospital
Parel
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
912224177000 |
| Fax |
|
| Email |
prachipatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| This trial has no funding and will be conducted at the Tata Memorial Center, Dr. E Borges Rd, Parel, Mumbai 400012, India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road,
Parel, Mumbai 400012 |
| 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 Prachi Patil |
Tata Memorial Hospital |
Department of digestive diseases and clinical nutrition, Tata Memorial Hospital, Parel,
Mumbai
MAHARASHTRA |
912224177000
prachipatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee 1, Tata Memorial Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C220||Liver cell carcinoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Only adult patients more than equal to 18 years.
- who speak English Hindi and Marathi
- who are receiving a diagnosis and are undergoing evaluation or treatment of HCC at TMH Mumbai
will be included. |
|
| ExclusionCriteria |
| Details |
- Patient not willing for Informed Consent.
- Who are Minors |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
- To determine the frequency of prior ultrasound examination, 6-months prior to detection
of hepatocellular carcinoma. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| - To determine the stage of hepatocellular carcinoma (Milan criteria) at the time of detection of hepatocellular carcinoma. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
11/09/2024 |
| 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="1"
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
|
Patients at risk of developing hepatocellular carcinoma, particularly those with cirrhosis of liver, are advised to have six-monthly surveillance by ultrasound examination. However, the effect of implementation of this recommendation on the detection of hepatocellular carcinoma in India is not known.Therefore, a representative patient survey will be conducted and coordinated by VPS Lakeshore hospital to determine the frequency of prior ultrasound examination, 6-months prior to detection of hepatocellular carcinoma.Also, to determine the stage of hepatocellular carcinoma (Milan criteria) at the time of detection of hepatocellular carcinoma. |