Lung Cancer | Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study
Lung Cancer research study
What is the primary objective of this study?
Haemoptysis is the coughing up of blood originating from the respiratory tract. It is a common and worrying clinical symptom which can be due to different aetiologies including lung cancer, tuberculosis, COPD, bronchiectasis, pneumonia, acute bronchitis or unknown origin (cryptogenic haemoptysis). Epidemiology and optimal diagnostic approach are largely unclear. Aims of this study are to define current epidemiology and to provide the best diagnostic approach by providing a diagnostic algorithm.
Who is eligible to participate?
Inclusion Criteria: - haemoptysis requiring a diagnosis Exclusion Criteria: - history of known bleeding lesions in the upper or lower airways
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Obstructive Pulmonary Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:computed tomography of the chest
Procedure:BronchoscopyIn patients with haemoptysis bronchoscopy will be performed with flexible bronchoscope. A systemic research of bleeding site and causes will be done. Microbiological or pathological sampling will be executed if clinically required. In selected patients, bronchoscopy might be performed with the rigid instrument or the flexible bronchoscope in intubated patients.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Patients presenting with haemoptysis
Start Date: June 2013
Type: Observational [Patient Registry]
Primary Outcome: Percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes.
Secondary Outcome: Sensitivity and specificity of chest X-ray, chest CT scan and bronchoscopy alone and in combination in the diagnosis of different causes of haemoptysis.
Study sponsors, principal investigator, and references
Principal Investigator: Michele Mondoni, MD
Lead Sponsor: University of Milan