Circulating Tumor Cells in mCRC for Liver Resection

November 17, 2018 updated by: Dr. Lam Ka On, The University of Hong Kong

Optimizing the Selection of Patients With Metastatic Colorectal Cancer for Liver Resection - An Immuno-clinical Scoring System Incorporating Circulating Tumor Cell Enumeration and Clinical Factors

Resection of liver metastasis is potentially curative in patients with colorectal cancer bearing liver metastasis. However, early recurrence occurs in up to 30% in 3 months after liver resection. To optimize patient selection, the investigators propose to evaluate the the value of incorporating circulating tumor cells enumeration to clinical factors in a prospective study

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a single-center prospective study to evaluate the predictive value of circulating tumor cells (CTC) in patients with metastatic colorectal cancer who are planned to have curative resection of liver metastasis. Blood will be taken from patients within 7 days before liver resection. CTC enumeration is done by a highly-sensitive microfluidic platform for which CTC can be subsequently enumerated with or without sequencing performed. Patients are then followed up regularly with contrast CT scan for recurrence. The primary study endpoint is to define the cutoff value of CTC count in patients with early relapse < 6months after liver resection. Seventy-seven patients will be recruited in 24 months.

Study Type

Observational

Enrollment (Anticipated)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong
        • Contact:
          • Ka On Lam, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with colorectal cancer and liver metastasis who are planned for liver resection

Description

Inclusion Criteria:

  1. Age>=18 years
  2. Signed informed consent
  3. Histologically or cytologically confirmed colorectal adenocarcinoma
  4. Both primary tumor and liver metastases are amenable to curative resection.

Exclusion Criteria:

  1. Presence of extrahepatic metastasis
  2. History of other malignancies in the last 5 years
  3. Patients unable to comply with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutoff value of CTC counts
Time Frame: Progression free survival at 6 months
to identify patients with early relapse (<6 months) after liver resection as determined by the AUC under the ROC curve
Progression free survival at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A immuno-clinical scoring system
Time Frame: Progression free survival at 6 months
A system combining CTC count with clinical factors to stratify patients before liver resection
Progression free survival at 6 months
Progression free survival
Time Frame: up to 5 years
Time from liver resection to date of relapse or date of death, whichever is earlier
up to 5 years
Overall survival
Time Frame: up to 5 years
Time from liver resection to date of death
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Ka On Lam, MBBS, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Anticipated)

November 30, 2019

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 24, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 17, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW17-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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