CTCs and Novel Target Bio-marker Analysis for Prediction and Monitoring of Metastasis/Recurrence in Post-surgery Colorectal Cancer Patients Using MiSelect R Rare Cell System

August 14, 2018 updated by: MiCareo Taiwan Co., Ltd.
Despite the growing public awareness and recent progress in multimodality therapy to the colorectal cancer (CRC), CRC still ranks high on the list of the most common and deadly cancers in Taiwan. The cause of CRC mortality is due mainly to the occurrence of distant metastasis. Several reports suggested that circulating tumor cells (CTCs) highly associated with metastasis suggesting that targeting CTCs may offer an unprecedented opportunity to prevent the development of metastasis. Early detection and characterization of CTCs is therefore important as a potential strategy to monitor the progression of CRC. The current proposal is focused on detecting CTCs from peripheral blood of CRC patients using Miselect R system. We will monitor the amount of CTCs and correlate with CRC progression and prognosis.

Study Overview

Status

Unknown

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Locations

      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital

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

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

200 Colorectal cancer stage II/III patients who will undergo surgical resection

Description

Inclusion Criteria:

  1. Over 20 and less than 90 years of age.
  2. Colorectal cancer stage II/III patients who will undergo surgical resection.
  3. Subject having agreed to participate in the study and follow the study procedures by providing written informed consent prior entering the study.

Exclusion Criteria:

  1. Have other cancer history.
  2. Subject being identified with any blood borne infectious disease

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease Free Survival
Time Frame: 5 years
5 years

Collaborators and Investigators

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

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

October 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (ESTIMATE)

January 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

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.

Clinical Trials on Circulating Tumor Cells, CTC

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