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Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03326570
Recruitment Status : Completed
First Posted : October 31, 2017
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment
Lung Cancer Behavioral: Medical Data Collection

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 Design
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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction
Actual Study Start Date : August 25, 2011
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Quality-Adjusted Survival [ Time Frame: 2 years ]
    Researchers will evaluate the relationship between covariates and quality-adjusted survival.


Other Outcome Measures:
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants scheduled for standard of care bronchoscopy at UT MD Anderson Cancer Center in Houston, Texas.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326570


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: David Ost, MD M.D. Anderson Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03326570    
Other Study ID Numbers: 2011-0563
NCI-2018-01276 ( Registry Identifier: NCI CTRP )
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Lung cancer
Data collection post bronchoscopy
Additional relevant MeSH terms:
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Airway Obstruction
Respiratory Tract Diseases
Respiratory Insufficiency
Respiration Disorders