Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer

NCT01799395 | Terminated

• 1 other identifier: 13002-Trisolini
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 5

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Predictor variables associated with the presence/occurrence of central airway obstruction

  12 months

• Prevalence of central airway obstruction

  1 day

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maggiore Bellaria Hospital, Bologna: lead

Study Sites (5)

Bentivoglio Hospital

Bentivoglio, Emilia-Romagna, 40010, Italy

Location

Bellaria Hospital

Bologna, Emilia-Romagna, 40100, Italy

Location

Maggiore Hospital

Bologna, Emilia-Romagna, 4013, Italy

Location

Budrio Hospital

Budrio, Emilia-Romagna, 40054, Italy

Location

SS Salvatore Hospital

San Giovanni in Persiceto, Emilia-Romagna, 40017, Italy

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rocco Trisolini, M.D.

  Maggiore Bellaria Hospital, Bologna, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 23, 2013
• First Posted: February 26, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

IT (5)