Lung Inflammation and Lung Metastases From Breast Cancer

NCT01182519 | Completed

• 1 other identifier: 10-115
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

lung inflammation; lung metastases; 10-115

Outcome Measures

Primary Outcomes (1)

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

  in patients with breast cancer

  2 years

Secondary Outcomes (2)

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

  2 years

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

  2 years

Study Arms (2)

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

History of early breast cancer

History of early breast cancer and currently no evidence of disease

Behavioral: questionnaire, blood draw and urine sample

Interventions

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.

Diagnosed with metastatic breast cancer; History of early breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Weill Medical College of Cornell University: collaborator
• Vanderbilt University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Urine and Blood

MeSH Terms

Conditions

Breast Neoplasms; Pneumonia

Interventions

Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Clifford Hudis, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 16, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

US (1)