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

This study has been terminated.
(it's too slow to enroll suitable patients into this study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01543126
First Posted: March 2, 2012
Last Update Posted: July 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xichun Hu, Fudan University
February 27, 2012
March 2, 2012
July 26, 2013
February 2011
February 2013   (Final data collection date for primary outcome measure)
level of IL-6 and IL-8 [ Time Frame: 2 days ]
Same as current
Complete list of historical versions of study NCT01543126 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
IL-6 and IL-8 Level of Blood and Pleural Effusion During Chemotherapy in Metastatic Breast Cancer
A Prospective Study Assessing the Correlation Between Disease Prognosis and the Level of IL-6 and IL-8 Level in Blood and Pleural Effusion Before and After Chemotherapy in Patients With Metastatic Breast Cancer
Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease
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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
pleural effusion
Non-Probability Sample
metastatic breast cancer patients with pleural effusion
Metastatic Breast Cancer
Not Provided
pleural effusion
patients with pleural effusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
February 2013
February 2013   (Final data collection date for primary outcome measure)

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<UNL (<1.5 x UNL in patients with liver mets),ALT/AST< 1.5 x UNL (<2.5x UNL in patients with liver mets),AKP<5 x UNL(except bone mets),Cr<UNL;
  • Normal functions with heart, liver,renal and bone marrow;
  • Got ICF before enrollment;
  • Life expectancy more than 12 weeks.

Exclusion Criteria:

  • Pregnant or breast-feeding women or positive serum pregnancy test;
  • Uncontrolled brain metastases;
  • No recovery from previous radiation or accepted radiation within 4 weeks before enrollment;
  • Participation in any investigational drug study within 4 weeks preceding treatment start;
  • Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin;
  • Serious uncontrolled intercurrent infections;
  • Poor compliance.
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01543126
Fudan BR2011-06
No
Not Provided
Not Provided
Xichun Hu, Fudan University
Fudan University
Not Provided
Principal Investigator: Xichun Hu, MD.PhD Fudan University
Fudan University
July 2013