Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01799395
• Other study ID #: 13002-Trisolini
• Status: Terminated
• Phase: N/A
• First received: February 23, 2013
• Last updated: September 11, 2017
• Start date: February 2013
• Est. completion date: March 2015

Study information

• Verified date: September 2017
• Source: Maggiore Bellaria Hospital, Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age < 18 year

• Pregnancy

• Refusal to sign informed consent

Related Conditions & MeSH terms

• Airway Obstruction
• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Italy	Bentivoglio Hospital	Bentivoglio	Emilia Romagna
Italy	Bellaria Hospital	Bologna	Emilia Romagna
Italy	Maggiore Hospital	Bologna	Emilia Romagna
Italy	Budrio Hospital	Budrio	Emilia Romagna
Italy	SS Salvatore Hospital	San Giovanni in Persiceto	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Maggiore Bellaria Hospital, Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of central airway obstruction	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	Predictor variables associated with the presence/occurrence of central airway obstruction		12 months
Secondary	Prevalence of central airway obstruction	The prevalence of central airway obstruction will be evaluated at the time of diagnosis	1 day