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
|
|
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
|
|
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 |
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. |