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:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01543126
First received: February 27, 2012
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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
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 ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

metastatic breast cancer patients with pleural effusion

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01543126

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

No publications provided

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

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

ClinicalTrials.gov processed this record on August 20, 2014