Relationship Between Circulating Tumor Stem Cells and the Clinical Pathology

March 30, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

A Prospective Randomized Trial on the Relationship Between Circulating Tumor Stem Cells and the Clinical Pathology

The aim of this study is to establish a platform of detecting and sorting circulating tumor stem cells from peripheral blood in HCC patients; to investigate the relationship between circulating tumor stem cells and their effects on postoperative recurrence and metastasis, in order to provide a new therapeutic target for hepatocellular carcinoma treatment.

Study Overview

Study Type

Observational

Enrollment (Actual)

1000

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

    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern hepatobilliary surgery 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

250 healthy volunteers, 250 patients with hepatitis cirrhosis, 500 patients with HCC;

Description

Inclusion Criteria:

  1. Male or female patients > 18 years and <=70 years of age;
  2. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
  3. Patients who can understand this trial and have signed information consent

Exclusion Criteria:

  1. Reject to attend;
  2. Impossible to come to our hospital for physical examination regularly;
  3. Patients with other diseases which may affect the treatment mentioned

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

Cohorts and Interventions

Group / Cohort
healthy volunteers
matched group
hepatitis cirrhosis
negative group
hepatocellular carcinoma
patients with primary HCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the overall survival rate of each group
Time Frame: 3 years
3 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

December 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZD201200102-P1

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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