CTRI

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CTRI Number

CTRI/2020/09/027891 [Registered on: 18/09/2020] Trial Registered Prospectively

Last Modified On:

13/02/2021

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Developing a reliable and validated screening assay for hepatitis B associated liver cancers.

Scientific Title of Study

Development of a miRNA based screening assay for Hepatitis B virus (HBV) associated Hepatocellular Carcinoma (HCC).

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	SHILPAC
Designation	PhD Scholar
Affiliation	Manipal Institute of Virology Manipal Academy of Higher Education
Address	Manipal Institute of Virology Madhav Nagar Manipal Udupi Udupi KARNATAKA 576104 India
Phone	7349743071
Fax
Email	shilpa.c.edu@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Shiran Shetty
Designation	Professor and Head
Affiliation	Kasturba Medical College
Address	Department of Gastroenterology and Hepatology Kasturba Medical College Manipal Academy of Higher Education, Manipal Udupi KARNATAKA 576104 India
Phone	8861920517
Fax
Email	drshiran@gmail.com

Details of Contact Person
Public Query

Name	Dr Shiran Shetty
Designation	Professor and Head
Affiliation	Kasturba Medical College
Address	Department of Gastroenterology and Hepatology Kasturba Medical College Manipal Academy of Higher Education, Manipal Udupi KARNATAKA 576104 India
Phone	8861920517
Fax
Email	drshiran@gmail.com

Source of Monetary or Material Support

Manipal Academy of Higher Education

Primary Sponsor

Name	Manipal Academy of Higher Education
Address	Madhav Nagar Manipal Udupi Karnataka 576104
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 3
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr SHIRAN SHETTY	DEPARTMENT OF GASTROENTEROLOGY AND HEPATOLOGY	KASTURBA MEDICAL COLLEGE MANIPAL 576104 Udupi KARNATAKA	8861920517 drshiran@gmail.com
Dr RANJINI KUDVA	DEPARTMENT OF PATHOLOGY	KASTURBA MEDICAL COLLEGE MANIPAL 576104 Udupi KARNATAKA	9448984568 ranjini.kudva@manipal.edu
SHILPA C	MANIPAL INSTITUTE OF VIROLOGY	MADHAV NAGAR MANIPAL Udupi KARNATAKA	7349743071 shilpa.c.edu@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C220\|\|Liver cell carcinoma,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Chronic hepatitis B positive (HBsAg/Anti HBc IgG) with no radiological evidence of liver fibrosis. Chronic hepatitis B positive liver cirrhosis cases diagnosed with upper GI endoscopic data of esophageal/gastric varices, portal hypertension or radiological features. Anti-HBc IgG positive Hepatocellular carcinoma cases will be identified by ultrasonography or with or without histological evidence. Anti-HBc IgG negative hepatocellular carcinoma cases diagnosed by ultrasonography with or without histological evidence. Normal healthy controls.

ExclusionCriteria

Details

Patients with other liver diseases, pregnant women, individuals below 18 years of age, co-infection with HIV, Hepatitis C virus (HCV), serious concurrent medical illnesses like malignancy and uncontrolled diabetes mellitus will be excluded.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Our study will become a platform for developing highly specific multiple microRNA based screening assay for other cancers like HPV associated oropharyngeal and anal cancers for which there does not exist a recommended screening tool.	2 years

Secondary Outcome

Outcome	TimePoints
Tumour specific miRNA targets will facilitate drug development leading to precision medicine with minimal side effects	2 years

Target Sample Size

Total Sample Size="120"
Sample Size from India="120"
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)

21/09/2020

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="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Serum samples will be collected from study participants attending Gastroenterology OPD at Kasturba Medical College, a tertiary care hospital under Manipal Academy of Higher Education (MAHE). Formalin-fixed, paraffin-embedded tissue (FFPE) samples of hepatocellular carcinoma will also be procured from Department of Pathology. Virology workup will be carried out at the Manipal Institute of Virology under the Manipal Academy of Higher Education (MAHE). We will be screening serum samples of HBV positive carriers (controls), HBV positive cirrhosis and hepatocellular carcinoma cases with HBV positivity (Anti HBcAg positive) or without HBV association for 13 microRNAs (let-7e, miR-15a, miR-16, miR-21, miR-26b, miR-29b-3p, miR-126, miR-142-3p, miR-146b, miR-193a-5p, miR122, miR223, miR-192).