IL-6 and IL-8 Level of Blood and Pleural Effusion During Chemotherapy in Metastatic Breast Cancer
This study is currently recruiting participants.
Verified November 2012 by Fudan University
Sponsor:
Fudan University
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01543126
First received: February 27, 2012
Last updated: November 13, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543126
Contacts
| Contact: Sheng Zhang, MD.PhD | 13795218205 | wozhangsheng@hotmail.com |
Locations
| China | |
| Fudan University Cancer Hospital | Recruiting |
| 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: | November 13, 2012 |
| 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 May 22, 2013