Clinical Trial of Quantitative Detection Kit for Hsp90α i... | NCT02324101

Studies
Clinical Trial of Quantitative Detection Kit for Hsp90α in Breast Cancer

NCT02324101

Sponsor

Protgen Ltd

Status

Unknown status

Last Update Posted

Dec 24, 2014Estimated

Enrollment

1,100Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Hsp90

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Dec 14, 2014

First Submission Date that Met QC Criteria

Dec 22, 2014

First Posted Date

Dec 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2014

Last Update Posted Date

Dec 24, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breast cancer	Experimental	Detect plasma Hsp90α concentration of breast cancer patients	Device: Hsp90

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hsp90	Device	Detect plasma Hsp90α concentration	Breast cancer	Biomarker

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hsp90α Concentration(ng/ml) of plasma	Detect Hsp90α Concentration(ng/ml) of plasma and calculate the accuracy, specificity and sensitivity of Hsp90α kit	4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

breast cancer patients, healthy volunteers, benign breast diseases patients

Exclusion Criteria:

Patients who previously received radiotherapy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhongsheng Tong, MD	Contact	022	23340123
Fei Wu, MD	Contact	010	62783351	wufei@protgen.com

Overall Officials

Name	Affiliation	Role
Zhongsheng Tong, MD	Tianjin cance hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin cancer hospital	Recruiting	Tianjin	Tianjin Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided