Breast CancerNCT01182519
Lung Inflammation and Lung Metastases From Breast Cancer
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out if there is a link between cigarette smoking, inflammation and the spread of breast cancer to the lung. We think that women who are current or former smokers may be at increased risk for breast cancer spreading to the lung compared to women who have never smoked. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- questionnaire, blood draw and urine sample
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jul 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients who meet the above inclusion and exclusion criteria will be approached by a member of the study team and be asked to participate.
Who may be able to join
- Registered patient at MSKCC
- Histologically proven breast cancer. It is not necessary that pathology be reviewed at MSKCC
- Age ≥18 years Group 1 (A and B)
- Diagnosed with metastatic breast cancer on biopsy or imaging study.
- Patients will be considered to have lung metastases, and will be assigned to group 1A if any of the following criteria are met, otherwise patients will be assigned to group 1B "No known Lung Metastases," Biopsy-proven lung metastasis.
- Pleural effusion with cytologic evidence of malignancy.
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- Pleural effusion, exudative in character, without alternative explanation and attributed, in the opinion of the clinician to metastatic disease.
- Symptoms attributable to lung metastases and a radiological pattern interpreted by a radiologist as suspicious for metastatic disease.
- Any pulmonary nodule on chest radiograph, CT scan, PET-CT or MRI, which is interpreted by the clinician and radiologist to be metastatic in etiology, whether or not a biopsy was performed, and regardless of symptoms.
- A radiographic pattern interpreted by a radiologist as consistent with lymphangitic carcinomatosis.
- Group 2 (Controls)
- History of early breast cancer and currently no evidence of disease
Who cannot join
- Inability to provide written informed consent.
- Inability to complete smoking and NSAID questionnaire.
- Steroid use within the previous 4 weeks.
- Radiotherapy to the breast, chest wall or axilla within the previous 3 months.
- Men with breast cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Association of Smoking, Lung Inflammation and Lung Metastases From Breast Cancer
The purpose of this study is to find out if there is a link between cigarette smoking, inflammation and the spread of breast cancer to the lung. We think that women who are current or former smokers may be at increased risk for breast cancer spreading to the lung compared to women who have never smoked. Smoking causes inflammation in the lung in some women. Researchers at Memorial Sloan-Kettering (MSKCC) think that smoking-related lung inflammation may increase the chance of breast cancer spreading to the lung. In order to find out whether inflammation plays a role in breast cancer spreading to the lung, we will measure a urinary marker of lung inflammation. This will allow us to determine if this marker is more commonly elevated in women with breast cancer that has spread to the lung compared to those without breast cancer in the lung. We will also collect DNA from blood to have the opportunity to determine if there are differences in DNA in women with or without breast cancer that has spread to the other sites including the lung. We will also collect blood to determine if we can identify risk factors for the spread of breast cancer to the lungs.
- Conditions
- Breast Cancer
- Being tested
- questionnaire, blood draw and urine sample
- Keywords
- lung inflammation, lung metastases, 10-115
- Medical subject headings
- Breast Neoplasms, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire, blood draw and urine sampleBehavioural
Patients will be asked to participate on a single day. After study registration they will be asked to complete the questionnaire. All participants will complete a questionnaire detailing tobacco and NSAID exposure, as well as detailing any other inflammatory conditions of the lung. Then the patient will give a single blood sample (up to 3 tubes) and a single urine sample.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with metastatic breast cancer | The primary objective of this study is to examine the association between urinary PGE-M and the presence or absence of lung metastases in patients with breast cancer. These patients will be subdivided into a set with lung metastases (group 1A; clinically assessed as per guidelines below) versus those with no evidence of lung metastases (group 1B; "no known lung metastases"). Group #2 (control) will have been treated for early stage breast cancer and will have no known metastases. Receives: Behavioral: questionnaire, blood draw and urine sample | |
| History of early breast cancer | History of early breast cancer and currently no evidence of disease Receives: Behavioral: questionnaire, blood draw and urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between urinary PGE-M and the presence or absence of lung metastases
in patients with breast cancer
Measured: 2 years
Secondary outcomes (2)
The putative link between smoking and site-specific metastases from breast cancer
Measured: 2 years
Polymorphisms for genes linked to inflammation (germ line DNA SNPs)
with the presence or absence of lung metastases.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- Clifford Hudis, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182519
- Sponsor's protocol ID
- 10-115
- Status last verified
- Jul 2016
- First submitted
- 13 Aug 2010
- Last updated
- 12 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Smoking, Lung Inflammation and Lung Metastases From Breast Cancer
- ClinicalTrials.gov ID
- NCT01182519
- Acronym / sponsor ID
- 10-115
- Conditions
- Breast Cancer
- Keywords
- lung inflammation, lung metastases, 10-115
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, Vanderbilt University
- Study start
- Aug 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Aug 2010 (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.
The purpose of this study is to find out if there is a link between cigarette smoking, inflammation and the spread of breast cancer to the lung. We think that women who are current or former smokers may be at increased risk for breast cancer spreading to the lung compared to women who have never smoked. Smoking causes inflammation in the lung in some women. Researchers at Memorial Sloan-Kettering (MSKCC) think that smoking-related lung inflammation may increase the chance of breast cancer spreading to the lung. In order to find out whether inflammation plays a role in breast cancer spreading to the lung, we will measure a urinary marker of lung inflammation. This will allow us to determine if this marker is more commonly elevated in women with breast cancer that has spread to the lung compared to those without breast cancer in the lung. We will also collect DNA from blood to have the opportunity to determine if there are differences in DNA in women with or without breast cancer that has spread to the other sites including the lung. We will also collect blood to determine if we can identify risk factors for the spread of breast cancer to the lungs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnosed with metastatic breast cancer | – | Behavioral: questionnaire, blood draw and urine sampleThe primary objective of this study is to examine the association between urinary PGE-M and the presence or absence of lung metastases in patients with breast cancer. These patients will be subdivided into a set with lung metastases (group 1A; clinically assessed as per guidelines below) versus those with no evidence of lung metastases (group 1B; "no known lung metastases"). Group #2 (control) will have been treated for early stage breast cancer and will have no known metastases. |
| History of early breast cancer | – | Behavioral: questionnaire, blood draw and urine sampleHistory of early breast cancer and currently no evidence of disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the above inclusion and exclusion criteria will be approached by a member of the study team and be asked to participate.
Key inclusion criteria (12 listed)
- Registered patient at MSKCC
- Histologically proven breast cancer. It is not necessary that pathology be reviewed at MSKCC
- Age ≥18 years Group 1 (A and B)
- Diagnosed with metastatic breast cancer on biopsy or imaging study.
- Patients will be considered to have lung metastases, and will be assigned to group 1A if any of the following criteria are met, otherwise patients will be assigned to group 1B "No known Lung Metastases," Biopsy-proven lung metastasis.
Key exclusion criteria (5 listed)
- Inability to provide written informed consent.
- Inability to complete smoking and NSAID questionnaire.
- Steroid use within the previous 4 weeks.
- Radiotherapy to the breast, chest wall or axilla within the previous 3 months.
- Men with breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire, blood draw and urine samplePatients will be asked to participate on a single day. After study registration they will be asked to complete the questionnaire. All participants will complete a questionnaire detailing tobacco and NSAID exposure, as well as detailing any other inflammatory conditions of the lung. Then the patient will give a single blood sample (up to 3 tubes) and a single urine sample. | Behavioural | Diagnosed with metastatic breast cancer, History of early breast cancer |
Primary outcome
The association between urinary PGE-M and the presence or absence of lung metastases
Time frame: 2 years
in patients with breast cancer
2 secondary outcomes
The putative link between smoking and site-specific metastases from breast cancer
Time frame: 2 years
Polymorphisms for genes linked to inflammation (germ line DNA SNPs)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Clifford Hudis, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 12 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jul 2016. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The association between urinary PGE-M and the presence or absence of lung metastases (time frame: 2 years). 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 12 Jul 2016.