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Clinical Trial of Quantitative Detection Kit for Hsp90α in Hepatic Cancer

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ClinicalTrials.gov Identifier: NCT02324127
Recruitment Status : Unknown
Verified December 2014 by Protgen Ltd.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2014
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
Protgen Ltd

Tracking Information
First Submitted Date  ICMJE December 14, 2014
First Posted Date  ICMJE December 24, 2014
Last Update Posted Date December 24, 2014
Study Start Date  ICMJE October 2012
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2014)
Hsp90α Concentration of plasma [ Time Frame: 4 months ]
Detect Hsp90α Concentration(ng/ml) of plasma and calculate the accuracy, specificity and sensitivity of Hsp90α kit
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Quantitative Detection Kit for Hsp90α in Hepatic Cancer
Official Title  ICMJE Clinical Trial of Quantitative Detection Kit for Hsp90α in Hepatic Cancer
Brief Summary Detect plasma Hsp90α concentration of liver cancer patients, healthy volunteers, benign liver diseases.
Detailed Description Detect plasma Hsp90α concentration of liver cancer patients, healthy volunteers, benign liver diseases, validate accuracy, specificity and sensitivity of Hsp90α kit.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Liver Cancer
Intervention  ICMJE Device: hsp90
Detect plasma Hsp90α concentration of lung cancer patients
Other Name: biomarker
Study Arms  ICMJE Experimental: liver cancer
Detect plasma Hsp90α concentration of liver cancer patients
Intervention: Device: hsp90
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  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 23, 2014)
1100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Liver cancer patients
  • Healthy volunteers,
  • Benign liver diseases patients

Exclusion Criteria:

  • Patients who Previously accepted radiotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02324127
Other Study ID Numbers  ICMJE hsp90a2011-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Protgen Ltd
Study Sponsor  ICMJE Protgen Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shusen Zhen, MD The first hospital of Zhejiang province
PRS Account Protgen Ltd
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP