IL-6 and IL-8 Level of Blood and Pleural Effusion During... | NCT01543126

Studies
IL-6 and IL-8 Level of Blood and Pleural Effusion During Chemotherapy in Metastatic Breast Cancer

NCT01543126

Sponsor

Fudan University

Status

Terminated

Last Update Posted

Jul 26, 2013Estimated

Enrollment

9Actual

Phase

Not provided

Conditions

Metastatic Breast Cancer

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

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

it's too slow to enroll suitable patients into this study

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Feb 27, 2012

First Submission Date that Met QC Criteria

Feb 27, 2012

First Posted Date

Mar 2, 2012Estimated

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

Jul 24, 2013

Last Update Posted Date

Jul 26, 2013Estimated

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

Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease

Detailed Description

To assess the correlation between the disease prognosis and the level of IL-6 and IL-8 in blood and pleural effusion before and after chemotherapy in patients with metastatic breast cancer

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

9Actual

Label	Type	Description	Intervention Names
pleural effusion		patients with pleural effusion

Measure	Description	Time Frame
level of IL-6 and IL-8		2 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female between 18 and 70 years old;
Patients with histologic proved metastatic breast cancer;
Pleural effusion with the volume of more than 1000ml, as documented by CT, X ray or ultrasound;
There are no other diseases which cause the elevation of IL-6 or IL-8, such as cirrhosis of liver, anaphylactoid purpura, acute pancreatitis;
With at least one measurable disease according to RECIST criteria,
Normal laboratory results:ANC≥2.0×109/L,Hb≥80g/L,plt≥100×109/L,TB\

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

metastatic breast cancer patients with pleural effusion

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xichun Hu, MD.PhD	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Cancer Hospital		Shanghai		200032	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