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

NCT01543126 | Terminated

• 1 other identifier: Fudan BR2011-06
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• level of IL-6 and IL-8

  2 days

Study Arms (1)

pleural effusion

patients with pleural effusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

metastatic breast cancer patients with pleural effusion

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

pleural effusion

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xichun Hu, MD.PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 2, 2012
• Study Start: February 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: July 26, 2013

Record last verified: 2013-07

Locations

CN (1)