| CTRI Number |
CTRI/2023/02/049609 [Registered on: 10/02/2023] Trial Registered Prospectively |
| Last Modified On: |
07/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Longitudinal Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study of liver cancer |
|
Scientific Title of Study
|
A study of clinical profile of hepatocellular carcinoma in a tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahil Ahmad |
| Designation |
Postgraduate General Medicine |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College, Manipal
Department of Medicine
Medicine OPD 2nd floor
MAHE Campus NIH B block
Room 407
Pin code:576104
Manipal
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9634000274 |
| Fax |
|
| Email |
sahil151718@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shubha Seshadri |
| Designation |
Guide |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College, Manipal
Department of Medicine
Medicine OPD 2nd floor
Udupi
KARNATAKA
576104
India |
| Phone |
9845563799 |
| Fax |
|
| Email |
shubhamanipal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Shubha Seshadri |
| Designation |
Guide |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College, Manipal
Department of Medicine
Medicine OPD 2nd floor
Udupi
KARNATAKA
576104
India |
| Phone |
9845563799 |
| Fax |
|
| Email |
shubhamanipal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal
Department of Medicine
Pin code:576104
Manipal
Karnataka |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College, Manipal
Department of Medicine
Pin code:576104
Manipal
Karnataka |
| 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 |
| Sahil Ahmad |
Kasturba Medical College, Manipal |
Kasturba Medical College, Manipal
OPD Block
Department of Medicine
2nd floor
Pin code:576104
Manipal
Karnataka
Udupi
KARNATAKA |
9634000274
sahil151718@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Manipal |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed hepatocellular carcinoma cases and already diagnosed cases on follow up |
|
| ExclusionCriteria |
| Details |
Age less than 18 years |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the clinical profile of Hepatocellular Carcinoma using history, examination, lab parameters and radiological investigations. Barcelona Clinic Liver Cancer
Staging System (BCLC) will be used to assess the severity at presentation.
|
Newly diagnosed Hepatocellular carcinoma patients and already diagnosed cases on follow up to Kasturba Hospital, Manipal during the period of study of 1 year and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowing the clinical profile of the patient and correlating it to the severity of hepatocellular carcinoma at presentation can help predict the course of the disease and thus help adopt appropriate treatment course to reduce the morbidity and mortality. |
Newly diagnosed Hepatocellular carcinoma patients and already diagnosed cases on follow up to Kasturba Hospital, Manipal during the period of study of 1 year and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/02/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Type of study: Prospective Observational Longitudinal Study
Aims: To study the clinical profile of Hepatocellular Carcinoma in a tertiary care hospital.
Objective: To study the following in hepatocellular carcinoma patients: 1) Age and gender, history, examination and lab parameters 2) Risk factors-HBV, HCV, Diabetes mellitus, Alcoholic liver disease, NASH, NAFLD, pre-existing cirrhosis of liver 3) Alpha-fetoprotein level and its correlation with tumor size by imaging-USG/CECT/MRI Abdomen 4) Barcelona Clinic Liver Cancer Staging System(BCLC) will be used to assess the severity at presentation.
Sample size: This is a Time bound study. Sample size calculation is not applicable. However considering that hepatocellular carcinoma has a relatively low prevalence, we expect a sample size of atleast 50 to be taken up during our study period of 1 year and 6 months. |