Lung Function Testing in Patients With Locally Advanced or Metastatic Solid Tumors

Not Applicable

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Procedure: pulmonary function testing

• Registration Number: NCT00914147
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Brief Summary

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.

Detailed Description

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.

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2012-08-23
• Study Completion: 2012-08-23
• Status Verified: 2020-05
• Last Update Submitted: 2021-02-26
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary Function Test (PFT)	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. 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)

Primary Outcome Measures

Name	Time	Method
DLCO, FVC, and FEV1 as measured by pulmonary function testing	Prior to participation in a Phase I trial

Trial Locations

Locations (1)

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States