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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-2009-004 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Measuring how well the lungs work in patients with cancer may help doctors predict how patients will respond to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying lung function testing in patients with locally advanced or metastatic solid tumors.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo pulmonary function testing comprising spirometry test, lung volumes, and DLCO measurement utilizing the single-breath breath-holding technique. Patients then proceed to treatment on a phase I clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Function Test (PFT) | Other | After signing consent, patients will undergo a complete spirometry test, lung volumes and diffusing capacity (DLCO) measurement utilizing the single-breath breath holding technique, according to the ATS/ERS consensus and standardization. PFT measurements will be reported as absolute values (e.g. liters) and percentage of predicted. The predicted normal values will be calculated according to sex, age, height and race using the Third National Health and Nutrition Examination Survey (NHANES III) reference equation. Predicted values for diffusion capacity will be calculated using the Morris/Polgar equation. DLCO values will be adjusted to anemia (hemoglobin levels) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulmonary function testing | Procedure | After signing consent, patients will undergo a complete spirometry test, lung volumes and diffusing capacity (DLCO) measurement utilizing the single-breath breath holding technique, according to the ATS/ERS consensus and standardization. |
| Measure | Description | Time Frame |
|---|---|---|
| DLCO, FVC, and FEV1 as measured by pulmonary function testing | Prior to participation in a Phase I trial |
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DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
Disease progressed on or after standard therapy OR there is no standard therapy for the malignancy
Life-long non-smoker
No lung metastasis and/or pleural effusion causing signs or symptoms that impact patient performance status
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Body mass index ≤ 35
No concurrent uncontrolled illness including, but not limited to, the following:
No uncontrolled chest or abdominal pain
No oral or facial pain exacerbated by an oral device
No stress incontinence
No COPD, interstitial lung disease, pulmonary embolism, or hemorrhage within the past 6 months
No history of pulmonary fibrosis or pulmonary hypertension
No oxygen requirement at baseline
No asthma
No occupational lung disease, including, but not limited to, asbestos exposure
No polycythemia
No history of connective tissue disease
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Ulka N. Vaishampayan, M.D. | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
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| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| ID | Term |
|---|---|
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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