THE ROLE OF CIRCULATING TUMOUR CELLS AS EARLY PREDICTORS OF TUMOUR RECURRENCE AFTER SURGERY FOR HEPATOCELLULAR CARCINOMA

Recruiting

Conditions: Liver cell carcinoma,

Registration Number: CTRI/2023/04/051771

Lead Sponsor: MOHAMED RELA

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 â€œseedsâ€ 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 50

Inclusion Criteria

All Hepatocellular carcinoma patients who undergo resection or liver transplantation with a curative intent.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-Surgical Recurrence of Hepatocellular carcinoma	Day 1, Day 7, Day 14, Day 30, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 24 months
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Dr Rela Institute and Medical Centre
🇮🇳
Chennai, TAMIL NADU, India
Dr Rela Institute and Medical Centre
🇮🇳Chennai, TAMIL NADU, India
Mohamed Rela
Principal investigator
9884173583
mohamed.rela@gmail.com