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Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer

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ClinicalTrials.gov Identifier: NCT01799395
Recruitment Status : Terminated (Staff constraints made it impossibile to enroll consecutive patients, making the sample not representative of the true cancer population)
First Posted : February 26, 2013
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Rocco Trisolini, Maggiore Bellaria Hospital, Bologna

Study Description
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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.


Condition or disease
Lung Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence, Incidence and Predictors of Central Airway Obstruction in Patients With Advanced Lung Cancer
Study Start Date : February 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Predictor variables associated with the presence/occurrence of central airway obstruction [ Time Frame: 12 months ]
  2. Prevalence of central airway obstruction [ Time Frame: 1 day ]
    The prevalence of central airway obstruction will be evaluated at the time of diagnosis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799395


Locations
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Italy
Bentivoglio Hospital
Bentivoglio, Emilia Romagna, Italy, 40010
Bellaria Hospital
Bologna, Emilia Romagna, Italy, 40100
Maggiore Hospital
Bologna, Emilia Romagna, Italy, 4013
Budrio Hospital
Budrio, Emilia Romagna, Italy, 40054
SS Salvatore Hospital
San Giovanni in Persiceto, Emilia Romagna, Italy, 40017
Sponsors and Collaborators
Maggiore Bellaria Hospital, Bologna
Investigators
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Principal Investigator: Rocco Trisolini, M.D. Maggiore Bellaria Hospital, Bologna, Italy
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Rocco Trisolini, M.D., Maggiore Bellaria Hospital, Bologna
ClinicalTrials.gov Identifier: NCT01799395    
Other Study ID Numbers: 13002-Trisolini
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Lung Neoplasms
Airway Obstruction
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiratory Insufficiency
Respiration Disorders