Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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