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Trial #NCT01799395
Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer
Prevalence, Incidence and Predictors of Central Airway Obstruction in Patients With Advanced Lung Cancer
Study ID: 13002-Trisolini; Source: Maggiore Bellaria Hospital, Bologna
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Definitions
- Interventional trials
- Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
- Observational trials
- Address health issues in large groups of people or populations in natural settings.
- Recruiting
- Participants are currently being recruited and enrolled.
- Active, not recruiting
- Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
- Not yet recruiting
- Participants are not yet being recruited or enrolled.
- Enrolling by invitation
- Participants are being (or will be) selected from a predetermined population.
- Completed
- The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
- Withdrawn
- Study halted prematurely, prior to enrollment of first participant.
- Suspended
- Recruiting or enrolling participants has halted prematurely but potentially will resume.
- Terminated
- Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
|
| Status |
Recruiting |
| Country |
Italy |
| Study type |
Observational |
| Enrollment |
150 |
| Start date |
February 2013 |
| Completion date |
March 2015 |
| Phase |
N/A |
| Sponsor |
Maggiore Bellaria Hospital, Bologna |
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.
Eligibility:
Gender: Both
Age: 18 Years - 85 Years
Inclusion Criteria:
- Advanced lung cancer with indication for chemotherapy or chemotherapy + radiation
therapy
Exclusion Criteria:
- Age < 18 year
- Pregnancy
- Refusal to sign informed consent
Outcome:
Primary outcome
- 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)
Time frame: 12 months
Secondary outcome
- Predictor variables associated with the presence/occurrence of central airway obstruction
Time frame: 12 months - Prevalence of central airway obstruction
The prevalence of central airway obstruction will be evaluated at the time of diagnosis
Time frame: 1 day
Contacts:
- Rocco Trisolini, M.D.; Maggiore Bellaria Hospital, Bologna, Italy (Principal Investigator)
- Rocco Trisolini, M.D.;
Phone: 0039-051-6478802
| Location |
Country |
Status |
| Bentivoglio Hospital |
Bentivoglio, Emilia Romagna |
Italy |
Recruiting |
| Bellaria Hospital |
Bologna, Emilia Romagna |
Italy |
Recruiting |
| Maggiore Hospital |
Bologna, Emilia Romagna |
Italy |
Recruiting |
| Budrio Hospital |
Budrio, Emilia Romagna |
Italy |
Recruiting |
| SS Salvatore Hospital |
San Giovanni in Persiceto, Emilia Romagna |
Italy |
Recruiting |
Sponsors:
- Maggiore Bellaria Hospital, Bologna - (Lead Sponsor)
|
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