IL-6 and IL-8 Level of Blood and Pleural Effusion During Chemotherapy in Metastatic Breast Cancer
Overview
Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease
Full Title of Study: “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 Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: February 2013
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
Arms, Groups and Cohorts
- pleural effusion
- patients with pleural effusion
Clinical Trial Outcome Measures
Primary Measures
- level of IL-6 and IL-8
- Time Frame: 2 days
Participating in This Clinical Trial
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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Fudan University
- Provider of Information About this Clinical Study
- Principal Investigator: Xichun Hu, Principal Investigator – Fudan University
- Overall Official(s)
- Xichun Hu, MD.PhD, Principal Investigator, Fudan University
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