Clinical trial · Interventional
Lung Function Testing in Patients With Locally Advanced or Metastatic Solid Tumors
Pulmonary Function Tests (PFT) in a Phase I Patient Population
NCT00914147CI-TRIAL-00050512completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pulmonary function testing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Pulmonary Function Test (PFT)
- description
- 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)
- interventionNames
- Procedure: pulmonary function testing
Primary outcomes (1)
- measure
- DLCO, FVC, and FEV1 as measured by pulmonary function testing
- timeFrame
- Prior to participation in a Phase I trial
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.