Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer

September 11, 2017 updated by: Rocco Trisolini, Maggiore Bellaria Hospital, Bologna

Prevalence, Incidence and Predictors of Central Airway Obstruction in Patients With Advanced Lung Cancer

Lung cancer may cause central airway obstruction through several different mechanisms (invasion by the primary tumor, invasion by metastatic lymph nodes, airway metastasis).

The aim of the present study is to determine the prevalence at the time of diagnosis, the incidence at 1 year from the diagnosis, and the predictors of central airway obstruction associated with advanced lung cancer.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

45

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

  • Italy
    • Emilia Romagna
      • Bentivoglio, Emilia Romagna, Italy, 40010
        • Bentivoglio Hospital
      • Bologna, Emilia Romagna, Italy, 40100
        • Bellaria Hospital
      • Bologna, Emilia Romagna, Italy, 4013
        • Maggiore Hospital
      • Budrio, Emilia Romagna, Italy, 40054
        • Budrio Hospital
      • San Giovanni in Persiceto, Emilia Romagna, Italy, 40017
        • SS Salvatore Hospital

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with advanced lung cancer undergoing treatment and follow-up at the Oncology Units of the Azienda USL di Bologna (government structure that manages several public hospitals that "cover" a 800.000 inhabitants area)

Description

Inclusion Criteria:

  • Advanced lung cancer with indication for chemotherapy or chemotherapy + radiation therapy

Exclusion Criteria:

  • Age < 18 year
  • Pregnancy
  • Refusal to sign informed consent

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
Lung Cancer
All patients with advanced lung cancer candidate for chemotherapy or chemotherapy + radiation therapy will be enrolled and followed-up for 1 year clinically and radiologically (Chest CT) to verify whether or not central airway obstruction is present at the time of diagnosis or occurs in the year following diagnosis (or in the life span from diagnosis and death in patients who die before 1 year of diagnosis). Furthermore, predictor variables possibly associated with central airway obstruction will be studied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of central airway obstruction
Time Frame: 12 months
The incidence will be measured over a 12 month period after diagnosis (or over the life span from diagnosis to death in patients who die before 1 year from the diagnosis)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictor variables associated with the presence/occurrence of central airway obstruction
Time Frame: 12 months
12 months
Prevalence of central airway obstruction
Time Frame: 1 day
The prevalence of central airway obstruction will be evaluated at the time of diagnosis
1 day

Collaborators and Investigators

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

Sponsor

Maggiore Bellaria Hospital, Bologna

Investigators

  • Principal Investigator: Rocco Trisolini, M.D., Maggiore Bellaria Hospital, Bologna, Italy

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

February 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

February 23, 2013

First Submitted That Met QC Criteria

February 23, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Actual)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13002-Trisolini

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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