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OpenTrials
Completed

NCT Number: NCT03326570

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.

Completed

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Data Collection

Behavioral

Medical information collected after bronchoscopy for up to 2 years.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Quality-Adjusted Survival

    Time frame: 2 years

    Researchers will evaluate the relationship between covariates and quality-adjusted survival.

Other outcomes

  1. 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. Late Intervention

    Time frame: 2 years

    Late intervention cases defined as those with moderate or severe dyspnea due to airway narrowing.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Comparative Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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