NCT03326570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2011

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

7.6 years

First QC Date

October 20, 2017

Last Update Submit

April 11, 2019

Conditions

Keywords

Lung cancerData collection post bronchoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality-Adjusted Survival

    2 years

Other Outcomes (2)

  • Early Intervention

    2 years

  • Late Intervention

    2 years

Study Arms (1)

Bronchoscopy Data Collection

Medical information collected after bronchoscopy for up to 2 years.

Behavioral: Medical Data Collection

Interventions

Medical information collected after bronchoscopy for up to 2 years.

Bronchoscopy Data Collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ° 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).

You may not qualify if:

  • Age less than 18 years,
  • Inability to participate in telephone follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Ong P, Grosu HB, Debiane L, Casal RF, Eapen GA, Jimenez CA, Noor L, Ost DE. Long-term quality-adjusted survival following therapeutic bronchoscopy for malignant central airway obstruction. Thorax. 2019 Feb;74(2):141-156. doi: 10.1136/thoraxjnl-2018-211521. Epub 2018 Sep 25.

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • David Ost, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2017

First Posted

October 31, 2017

Study Start

August 25, 2011

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations