Lung Inflammation and Lung Metastases From Breast Cancer

NCT ID: NCT01182519

Last Updated: 2016-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2016-07-31

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

questionnaire, blood draw and urine sample

Intervention Type: BEHAVIORAL

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

questionnaire, blood draw and urine sample

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clifford Hudis, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan-Kettering Cancer Center

Other Identifiers

10-115

Identifier Type: -

Identifier Source: org_study_id