Lung Function Testing in Patients With Locally Advanced or Metastatic Solid Tumors
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.
|Unspecified Adult Solid Tumor, Protocol Specific||Procedure: pulmonary function testing|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Pulmonary Function Tests (PFT) in a Phase I Patient Population|
- DLCO, FVC, and FEV1 as measured by pulmonary function testing [ Time Frame: Prior to participation in a Phase I trial ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Pulmonary Function Test (PFT)
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)
Procedure: pulmonary function testing
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.
Other Name: PFT
- To obtain the distribution of DLCO, FVC, and FEV_1 by pulmonary function testing (PFT) in patients with heavily pretreated locally advanced or metastatic solid tumors referred to the Karmanos Cancer Institute (KCI) Phase I Clinical Trials Program.
- To estimate the mean DLCO to within 4 units (% of predicted) of the true mean with 95% confidence.
- To estimate the percentage of patients who meet the defined eligibility criteria (including PFT levels, especially DLCO) from the entire population enrolled in the KCI Phase I Clinical Trials Program.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914147
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Principal Investigator:||Ulka N. Vaishampayan, M.D.||Barbara Ann Karmanos Cancer Institute|