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CTRI Number  CTRI/2023/04/051771 [Registered on: 19/04/2023] Trial Registered Prospectively
Last Modified On: 03/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   THE ROLE OF CIRCULATING TUMOUR CELLS AS EARLY PREDICTORS OF TUMOUR RECURRENCE AFTER SURGERY FOR HEPATOCELLULAR CARCINOMA  
Scientific Title of Study   CIRCULATING TUMOR CELLS AS PREDICTORS OF RECURRENCE AFTER TRANSPLANT FOR HEPATOCELLULAR CARCINOMA  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR MADHUR PARDASANI 
Designation  FELLOW 
Affiliation  Dr RELA INSTITUTE AND MEDICAL CENTRE 
Address  Dr RELA INSTITUTE AND MEDICAL CENTRE CLC Works Road Chromepet

Chennai
TAMIL NADU
600044
India 
Phone  9823618457  
Fax    
Email  madhurpardasani88@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mohamed Rela 
Designation  Chairman and Managing Director 
Affiliation  Dr Rela Institute and Meical Centre 
Address  Institute of Liver Disease and Transplantation Dr RELA INSTITUTE AND MEDICAL CENTRE CLC Works Road Chromepet

Chennai
TAMIL NADU
600044
India 
Phone  9884173583  
Fax    
Email  mohamed.rela@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR MADHUR PARDASANI 
Designation  FELLOW 
Affiliation  Dr RELA INSTITUTE AND MEDICAL CENTRE 
Address  Dr RELA INSTITUTE AND MEDICAL CENTRE CLC Works Road Chromepet

Chennai
TAMIL NADU
600044
India 
Phone  9823618457  
Fax    
Email  madhurpardasani88@gmail.com  
 
Source of Monetary or Material Support  
Dr. Rela Institute and Medical Centre CLC Works Road Chromepet Chennai 600044 
 
Primary Sponsor  
Name  MOHAMED RELA 
Address  Dr Rela Institute and Medical Centre CLC Works Road Chromepet 600044 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mohamed Rela  Dr Rela Institute and Medical Centre  Room No: 206, II Floor, Block A, Institute of Liver Disease and Transplantation, Dr. Rela Institute and Medical Centre CLC Works Road, Chromepet
Chennai
TAMIL NADU 
9884173583

mohamed.rela@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DrRelaInstituteandMedicalCentre  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. All Hepatocellular carcinoma patients who undergo resection or liver transplantation with a curative intent 
 
ExclusionCriteria 
Details  1. Non-Hepatocellular carcinoma liver tumours
2. Hepatocellular carcinoma patients who have undergone management with a non-curative intent (TACE/TARE/MWA etc.)
3. Patients not able to follow-up
4. Patients unwilling for the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post-Surgical Recurrence of Hepatocellular carcinoma
Detected on CTC assay-correlating with image detected recurrence 
Day 1, Day 7, Day 14, Day 30, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Detect the lead-time between CTC rise and imaging
2. Prognosticate the risk of recurrence based on the first post-operative week delta-change in CTC after surgery 
Day-1, Day-0(intraoperative), Day 1, Day 7, Day 14, Day 30, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 24 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)   01/05/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
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  

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the fourth leading cause of cancer related deaths worldwide. Its incidence is increasing in developing countries because of chronic viral hepatitis and increasing incidence of NASH.

Resection or Transplantation are the surgical treatment options for patients with HCC. LT offers the benefits of curing the malignancy, removing the cirrhotic liver and is associated with lowest chances of recurrence. HCC is becoming one of the leading indications for LT. 5-year HCC recurrence following resection can be upto 35-50%. Despite using restrictive criteria for LT, tumor recurrence occurs in  about 15% to 20% of cases. Recurrence after resection can be dealt with salvage transplantation. Recurrences are associated with un-favorable prognosis. Identification of risk factors associated with recurrence forms the corner stone for patient selection and to modify factors that may reduce the chance of recurrence after surgery for HCC. Many prognostic criteria and markers have been proposed to identify risk factors for recurrence but none of them allow for precise identification of tumor recurrence or development of metastasis.

Accumulation of mutations, epigenetic alterations, evasion of cellular check points and abnormal molecular machinery are the pathogenetic mechanisms of cancers.  This uncontrolled proliferation along with the loss of contact inhibition at a localized site results in their spread from the index site. Within the tumour, microenvironment hypoxia, cytokines, and tumour growth factors induce epithelial-mesenchymal transition (EMT) and facilitate the detachment of cancer cells from the primary site. These circulating tumour cells (CTCs) or CTC clusters intravasate into the blood stream lodge themselves at the new secondary site and form the “seeds” of metastasis . Hence the identification, separation, quantification and characterization of CTCs has an important role in early cancer diagnosis, and prognosis. It also holds a huge potential in the field of curative intervention 

This study aims to test the efficacy of liquid biopsy in the form of quantification of circulating tumour cells of HCC to prognosticate, early detect recurrence following curative surgery for HCC.

 
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