An observational study in Lung Cancer, Tuberculosis and Bronchiectasis, sponsored by University of Milan. Completed at 6 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-03.
Sponsored by University of Milan · Observational
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.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's enrollment of 610 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of Milan is the lead sponsor of 183 studies on the registry; 28 are open to participants now.
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Inpatients and outpatients with haemoptysis requiring a diagnosis referred for medical consultation to italian university and clinical hospitals.
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Other: Chest X-ray · Other: computed tomography of the chest · Procedure: Bronchoscopy
Also known as: chest CT scan
In 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.
Percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes.
To define the prevalence of diseases presenting with haemoptysis by measuring percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes. Epidemiology will be analysed related to the severity of the symptom (mild haemoptysis: drops of blood or bloody sputum; moderate haemoptysis: \<500 ml/24 h, severe haemoptysis: 1-2 cups, as defined by Hirshberg et al. CHEST 1997).
Time frame: 18 months
Sensitivity and specificity of chest X-ray, chest CT scan and bronchoscopy alone and in combination in the diagnosis of different causes of haemoptysis.
Sensitivity, specificity, positive and negative predictive values of of chest X-ray, computed tomography (CT) scan and bronchoscopy executed alone versus the combination of the exams in the diagnosis of different causes of haemoptysis (lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis and other causes).
Time frame: 18 months
Percentage and severity of recurrence of haemoptysis in the follow-up period.
Every patient will be followed with scheduled visits and phone calls for 18 months since the first episode of haemoptysis. The percentage of patient with recurrence of haemoptysis, the severity of recurrence, will be measured and analysed by descriptive statistics.
Time frame: 18 months
Sensitivity and specificity of bronchoscopy in localizing the bleeding side and lobe in relation to the timing of the haemoptysis.
Accuracy of bronchoscopy in localizing the side and the lobe source of the bleeding in relation to the timing of haemoptysis. The bronchoscopic findings will be analysed in relation to the timing of the bleeding (within 24 hours, between 24 and 48, 49 and 96 or over 96 hours after the occurrence of the symptom).
Time frame: 18 months
Patient survival in the follow-up period.
Every patient will be followed with scheduled visits and phone calls for 18 months since the first episode of haemoptysis. Patient survival will be measured and analysed by descriptive statistics.
Time frame: 18 months
Prevalence of chronic obstructive pulmonary disease (COPD) in patients with haemoptysis by using spirometry with the threshold of FEV1/FVC <70
Prevalence of chronic obstructive pulmonary disease (COPD) in patients with haemoptysis will be assessed performing spirometry as described by European Respiratory Society Guidelines (European Respiratory Journal, 2005). COPD will be diagnosed in patient with a compatible clinical history (smoking history and frequent exacerbations) and the presence of a ventilatory obstructive defect as defined by a ratio of the forced expiratory volume in the first second and forced vital capacity (FEV1/FVC) \<70.
Time frame: 1 month or at clinical stability
Distribution of main causes of haemoptysis in the subgroup of patients undergoing medical therapies that increase the risk of bleeding.
To define the prevalence of diseases in patients presenting with haemoptysis in relation to the use of drugs such as antiaggregants or anticoagulants.
Time frame: 18 months
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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