Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer

• ClinicalTrials.gov Identifier: NCT01799395
• Recruitment Status: Terminated
• First Posted: February 26, 2013
• Last Update Posted: September 12, 2017
• Sponsor: Maggiore Bellaria Hospital, Bologna
• Information provided by (Responsible Party): Rocco Trisolini, Maggiore Bellaria Hospital, Bologna

Tracking Information

• First Submitted Date: February 23, 2013
• First Posted Date: February 26, 2013
• Last Update Posted Date: September 12, 2017
• Study Start Date: February 2013
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 23, 2013)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 23, 2013)

• Predictor variables associated with the presence/occurrence of central airway obstruction [ Time Frame: 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer
• Official Title: Prevalence, Incidence and Predictors of Central Airway Obstruction in Patients With Advanced Lung Cancer

Brief 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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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)
• Condition: Lung Cancer
• Intervention: Not Provided

Study Groups/Cohorts

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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 26, 2014): 45
• Original Estimated Enrollment (submitted: February 23, 2013): 150
• Actual Study Completion Date: March 2015
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01799395
• Other Study ID Numbers: 13002-Trisolini
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Rocco Trisolini, Maggiore Bellaria Hospital, Bologna
• Study Sponsor: Maggiore Bellaria Hospital, Bologna
• Collaborators: Not Provided

Investigators

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

• PRS Account: Maggiore Bellaria Hospital, Bologna
• Verification Date: September 2017