Pulmonary Function Tests (PFT) in a Phase I Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- DLCO, FVC, and FEV1 as measured by pulmonary function testing
研究概览
简要总结
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.
详细描述
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solid tumor
- •Locally advanced or metastatic disease
- •Disease progressed on or after standard therapy OR there is no standard therapy for the malignancy
- •Standard therapy is defined as first- or second-line therapy that has been shown to provide clinical benefit
- •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:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Ventricular arrhythmia
- •Psychiatric illness or social situation that would limit compliance with study requirements
- •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:
- •No prior radiotherapy to the lung
- •At least 6 months since prior lung surgery
- •No prior amiodarone hydrochloride
- •No prior high-dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究组 & 干预措施
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)
干预措施: pulmonary function testing (Procedure)
结局指标
主要结局
DLCO, FVC, and FEV1 as measured by pulmonary function testing
时间窗: Prior to participation in a Phase I trial
次要结局
未报告次要终点
研究者
Anthony F. Shields, MD PhD
Principal Investigator
Barbara Ann Karmanos Cancer Institute