CompletedNot applicableNCT01182519
Official study title

Lung Inflammation and Lung Metastases From Breast Cancer

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedquestionnaire, blood draw and urine sample

The study team can explain what participation involves.

Who it may be forBreast Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 12, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Memorial Sloan Kettering Cancer Center
Interventions being studied
Behavioral: questionnaire, blood draw and urine sample
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Sloan Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 12, 2016. Always confirm current availability with the study team.

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