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

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. Identifier: NCT01543126
Recruitment Status : Terminated (it's too slow to enroll suitable patients into this study)
First Posted : March 2, 2012
Last Update Posted : July 26, 2013
Information provided by (Responsible Party):
Xichun Hu, Fudan University

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

Condition or disease
Metastatic Breast Cancer

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

Study Type : Observational
Actual Enrollment : 9 participants
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
Study Start Date : February 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

pleural effusion
patients with pleural effusion

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

Biospecimen Retention:   Samples With DNA
pleural effusion

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01543126

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

Responsible Party: Xichun Hu, Principal Investigator, Fudan University Identifier: NCT01543126     History of Changes
Other Study ID Numbers: Fudan BR2011-06
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: July 26, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Breast Neoplasms
Pleural Effusion
Neoplasms by Site
Breast Diseases
Skin Diseases
Pleural Diseases
Respiratory Tract Diseases