Lung Inflammation and Lung Metastases From Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Weill Medical College of Cornell University
Vanderbilt University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01182519
First received: August 13, 2010
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: questionnaire, blood draw and urine sample

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Smoking, Lung Inflammation and Lung Metastases From Breast Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • The association between urinary PGE-M and the presence or absence of lung metastases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    in patients with breast cancer


Secondary Outcome Measures:
  • The putative link between smoking and site-specific metastases from breast cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Polymorphisms for genes linked to inflammation (germ line DNA SNPs) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    with the presence or absence of lung metastases.


Biospecimen Retention:   Samples With DNA

Urine and Blood


Estimated Enrollment: 400
Study Start Date: August 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Behavioral: questionnaire, blood draw and urine sample
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.
History of early breast cancer
History of early breast cancer and currently no evidence of disease
Behavioral: questionnaire, blood draw and urine sample
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182519

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Weill Medical College of Cornell University
Vanderbilt University
Investigators
Principal Investigator: Clifford Hudis, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01182519     History of Changes
Other Study ID Numbers: 10-115
Study First Received: August 13, 2010
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
lung inflammation
lung metastases
10-115

Additional relevant MeSH terms:
Breast Neoplasms
Inflammation
Neoplasm Metastasis
Pneumonia
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Neoplastic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014