Clinical Trial of Bile Etiology ,Proteomics and Metabonom... | NCT01073514

Studies
Clinical Trial of Bile Etiology ,Proteomics and Metabonomics of Malignant Biliary Obstruction

NCT01073514

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Unknown status

Last Update Posted

Dec 22, 2015Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Malignant Biliary Obstruction

Interventions

Not provided

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

ID	Type	Description	Link
ChiCTR-ONC-00000752	Registry Identifier	Chinese Clinical Trial Register(http://www.chictr.org)

Status Module

Record Verification Date

Feb 2010

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

Dec 2009

Primary Completion Date

Nov 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 21, 2010

First Submission Date that Met QC Criteria

Feb 22, 2010

First Posted Date

Feb 23, 2010Estimated

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 21, 2015

Last Update Posted Date

Dec 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To investigate bile culture and susceptibility test in patients with malignant biliary obstruction (MBO) or relation between bile, portal vein or vein culture and biliary infection. Also to get the information of bile metabonomics to find potential tumor marker .Culture of the organism is recognized as the "gold standard" for diagnosis of infection. Our research may be one of the first research on culture and susceptibility test in patients with MBO. The results of the trial research will be benefit to experiential therapy of MBO with biliary infection and diagnosis of MBO.

Detailed Description

We will obtain bile sample for culture and susceptibility ,proteomics metabonomics test after PTBD. Also get the blood and urine samples.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Those with MBO who can receive Percutaneous Transhepatic Biliary Drainage(PTBD)

Exclusion Criteria:

Those with MBO who cannot receive Percutaneous Transhepatic Biliary Drainage(PTBD)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Malignant obstructive jaundice (MBO)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
YU HAI PENG, MD	Contact	13352070835		JIERUKE@YAHOO.COM.CN

Overall Officials

Name	Affiliation	Role
YU HAI PENG, MD	Tianjin Medical University Cancer Institute and Hospital	Principal Investigator
GUO ZHI, Professor	Tianjin Medical University Cancer Institute and Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin Medical University Cancer Institude and Hospital	Recruiting	Tianjin	Tianjin Municipality	300060	China