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Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT03326570
Collaborator
(none)
110
Enrollment
1
Location
91.2
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

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 :
Aug 25, 2011
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. 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

  1. Quality-Adjusted Survival [2 years]

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

Other Outcome Measures

  1. Early Intervention [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 [2 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Texas MD Anderson Cancer Center Houston Texas United States 77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT03326570
Other Study ID Numbers:
  • 2011-0563
  • NCI-2018-01276
First Posted:
Oct 31, 2017
Last Update Posted:
Apr 16, 2019
Last Verified:
Apr 1, 2019
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:
Airway Obstruction

Study Results

No Results Posted as of Apr 16, 2019