Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction

Lung Cancer Clinical Trial

Official title:

Comparative Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326570
• Other study ID #: 2011-0563
• Secondary ID: NCI-2018-01276
• Status: Completed
• Start date: August 25, 2011
• Est. completion date: April 1, 2019

Study information

• Verified date: April 2019
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Lung Cancer

Intervention

Behavioral:
• Medical Data Collection
Medical information collected after bronchoscopy for up to 2 years.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Early Intervention	Early intervention cases defined as those with anatomic narrowing and no or mild dyspnea (as measured by the Borg score).	2 years
Other	Late Intervention	Late intervention cases defined as those with moderate or severe dyspnea due to airway narrowing.	2 years
Primary	Time to Any Complication Requiring Treatment	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.	2 years
Secondary	Quality-Adjusted Survival	Researchers will evaluate the relationship between covariates and quality-adjusted survival.	2 years

External Links

•   University of Texas MD Anderson Cancer Center Website