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Relationship Between Circulating Tumor Stem Cells and the Clinical Pathology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02727673
Recruitment Status : Completed
First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital

Tracking Information
First Submitted Date March 30, 2016
First Posted Date April 4, 2016
Last Update Posted Date April 4, 2016
Study Start Date December 2012
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2016)
the overall survival rate of each group [ Time Frame: 3 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relationship Between Circulating Tumor Stem Cells and the Clinical Pathology
Official Title A Prospective Randomized Trial on the Relationship Between Circulating Tumor Stem Cells and the Clinical Pathology
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 250 healthy volunteers, 250 patients with hepatitis cirrhosis, 500 patients with HCC;
Condition
  • Cancer Stem Cells
  • Postoperative Recurrence and Metastasis
  • Hepatocellular Carcinoma
Intervention Not Provided
Study Groups/Cohorts
  • healthy volunteers
    matched group
  • hepatitis cirrhosis
    negative group
  • hepatocellular carcinoma
    patients with primary HCC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 30, 2016)
1000
Original Actual Enrollment Same as current
Actual Study Completion Date December 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02727673
Other Study ID Numbers ZD201200102-P1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ShenFeng, Eastern Hepatobiliary Surgery Hospital
Study Sponsor Eastern Hepatobiliary Surgery Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Eastern Hepatobiliary Surgery Hospital
Verification Date March 2016