Lung Inflammation and Lung Metastases From Breast Cancer

Breast Cancer Clinical Trial

Official title:

Association of Smoking, Lung Inflammation and Lung Metastases From Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182519
• Other study ID #: 10-115
• Status: Completed
• Phase: N/A
• First received: August 13, 2010
• Last updated: July 11, 2016
• Start date: August 2010
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Inflammation
• Neoplasm Metastasis
• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Vanderbilt University, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The association between urinary PGE-M and the presence or absence of lung metastases	in patients with breast cancer	2 years	No
Secondary	The putative link between smoking and site-specific metastases from breast cancer		2 years	No
Secondary	Polymorphisms for genes linked to inflammation (germ line DNA SNPs)	with the presence or absence of lung metastases.	2 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center