Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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)
Information provided by (Responsible Party):
Xichun Hu, Fudan University Identifier:
First received: February 27, 2012
Last updated: July 24, 2013
Last verified: July 2013
Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease

Metastatic Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • level of IL-6 and IL-8 [ Time Frame: 2 days ]

Biospecimen Retention:   Samples With DNA
pleural effusion

Enrollment: 9
Study Start Date: February 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
pleural effusion
patients with pleural effusion

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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
metastatic breast cancer patients with pleural effusion

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01543126

Fudan University Cancer Hospital
Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Principal Investigator: Xichun Hu, MD.PhD Fudan University
  More Information

Responsible Party: Xichun Hu, Principal Investigator, Fudan University Identifier: NCT01543126     History of Changes
Other Study ID Numbers: Fudan BR2011-06
Study First Received: February 27, 2012
Last Updated: July 24, 2013

Additional relevant MeSH terms:
Breast Neoplasms
Pleural Effusion
Neoplasms by Site
Breast Diseases
Skin Diseases
Pleural Diseases
Respiratory Tract Diseases processed this record on April 28, 2017