Metastatic Breast CancerNCT01543126
IL-6 and IL-8 Level of Blood and Pleural Effusion During Chemotherapy in Metastatic Breast Cancer
An observational study of Metastatic Breast Cancer, run by Fudan University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: metastatic breast cancer patients with pleural effusion
Who may be able to join
- 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;
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- Normal functions with heart, liver,renal and bone marrow;
- Got ICF before enrollment;
- Life expectancy more than 12 weeks.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease
Read the 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
- Conditions
- Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pleural effusion | patients with pleural effusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of IL-6 and IL-8
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startFeb 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: it's too slow to enroll suitable patients into this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, MD.PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543126
- Sponsor's protocol ID
- Fudan BR2011-06
- Status last verified
- Jul 2013
- First submitted
- 27 Feb 2012
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01543126
- Acronym / sponsor ID
- Fudan BR2011-06
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: it's too slow to enroll suitable patients into this study
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pleural effusion | – | –patients with pleural effusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- metastatic breast cancer patients with pleural effusion
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
level of IL-6 and IL-8
Time frame: 2 days
Results and safety
The study was stopped early (reason given: it's too slow to enroll suitable patients into this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xichun Hu, MD.PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: it's too slow to enroll suitable patients into this study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of IL-6 and IL-8 (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2013.