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Completed

NCT Number: NCT01182519

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Infections Lung Diseases Neoplasms Neoplasms by Site Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

questionnaire, blood draw and urine sample

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.

Primary outcomes

  1. The association between urinary PGE-M and the presence or absence of lung metastases

    Time frame: 2 years

    in patients with breast cancer

Secondary outcomes

  1. The putative link between smoking and site-specific metastases from breast cancer

    Time frame: 2 years

  2. Polymorphisms for genes linked to inflammation (germ line DNA SNPs)

    Time frame: 2 years

    with the presence or absence of lung metastases.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Vanderbilt University
  • Weill Medical College of Cornell University

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Aug 16, 2010
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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