Back to resultsClinical Trial of Quantitative Detection Kit for Hsp90α in Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hsp90
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- breast cancer patients, healthy volunteers, benign breast diseases patients
Exclusion Criteria:
- Patients who previously received radiotherapy
Sites / Locations
- Tianjin cancer hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Breast cancer
Arm Description
Detect plasma Hsp90α concentration of breast cancer patients
Outcomes
Primary Outcome Measures
Hsp90α Concentration(ng/ml) of plasma
Detect Hsp90α Concentration(ng/ml) of plasma and calculate the accuracy, specificity and sensitivity of Hsp90α kit
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02324101
Brief Title
Clinical Trial of Quantitative Detection Kit for Hsp90α in Breast Cancer
Official Title
Clinical Trial of Quantitative Detection Kit for Hsp90α in Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Protgen Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients
Detailed Description
Detect plasma Hsp90α concentration of breast cancer patients, healthy volunteers, benign breast diseases patients, validate accuracy, specificity and sensitivity of Hsp90α kit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Breast cancer
Arm Type
Experimental
Arm Description
Detect plasma Hsp90α concentration of breast cancer patients
Intervention Type
Device
Intervention Name(s)
Hsp90
Other Intervention Name(s)
Biomarker
Intervention Description
Detect plasma Hsp90α concentration
Primary Outcome Measure Information:
Title
Hsp90α Concentration(ng/ml) of plasma
Description
Detect Hsp90α Concentration(ng/ml) of plasma and calculate the accuracy, specificity and sensitivity of Hsp90α kit
Time Frame
4 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
breast cancer patients, healthy volunteers, benign breast diseases patients
Exclusion Criteria:
Patients who previously received radiotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongsheng Tong, MD
Phone
022
Ext
23340123
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Wu, MD
Phone
010
Ext
62783351
Email
wufei@protgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong, MD
Organizational Affiliation
Tianjin cance hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin cancer hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong, MD
Phone
022
Ext
23340123
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of Quantitative Detection Kit for Hsp90α in Breast Cancer
We'll reach out to this number within 24 hrs