Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction

April 11, 2019 updated by: M.D. Anderson Cancer Center

Comparative Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants scheduled for standard of care bronchoscopy at UT MD Anderson Cancer Center in Houston, Texas.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bronchoscopy Data Collection
Medical information collected after bronchoscopy for up to 2 years.
Behavioral: Medical Data Collection
Medical information collected after bronchoscopy for up to 2 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Any Complication Requiring Treatment
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality-Adjusted Survival
Time Frame: 2 years
Researchers will evaluate the relationship between covariates and quality-adjusted survival.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Intervention
Time Frame: 2 years
Early intervention cases defined as those with anatomic narrowing and no or mild dyspnea (as measured by the Borg score).
2 years
Late Intervention
Time Frame: 2 years
Late intervention cases defined as those with moderate or severe dyspnea due to airway narrowing.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: David Ost, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2011

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0563
  • NCI-2018-01276 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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