Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction

Completed

• Conditions: Lung Cancer
• Interventions: Behavioral: Medical Data Collection

• Registration Number: NCT03326570
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The goal of this clinical research study is learn about side effects and the success of bronchoscopies when performed in cancer patients with and without symptoms.

This is an investigational study.

Up to 110 patients will take part in this study. All will be enrolled at MD Anderson.

Detailed Description

If participant agrees to take part in this study, researchers will collect information from participant's medical records.

Length of Study:

Researchers will continue to collect participant's medical information for up to 2 years.

Additional Information:

Participant's data will be kept in a database on a password-protected computer in a secure office. This information will only be available to the study doctors and staff.

Study Timeline

• Study Start: 2011-08-25
• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-31
• Status Verified: 2019-04
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

° All patients undergoing interventional bronchoscopy during the first 12 months will be enrolled, with follow-up occurring out to 2 years from the study startup (the duration of the grant).

Exclusion Criteria

• Age less than 18 years,
• Inability to participate in telephone follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bronchoscopy Data Collection	Medical Data Collection	Medical information collected after bronchoscopy for up to 2 years.

Primary Outcome Measures

Name	Time	Method
Time to Any Complication Requiring Treatment	2 years	Researchers will estimate the hazard function of time to any complications in the framework of competing risks while death is the competing risk.3 Researchers will graphically visualize the hazard function of time to any complications using Kernel smoothing method.

Secondary Outcome Measures

Name	Time	Method
Quality-Adjusted Survival	2 years	Researchers will evaluate the relationship between covariates and quality-adjusted survival.

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States