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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?

Lung Cancer

Tuberculosis

Bronchiectasis

Pneumonia

Acute Bronchitis

Chronic Obstructive Pulmonary Disease

Cryptogenic Haemoptysis

Study Interventions

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:Chest X-ray

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.

Study Arms

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

Study Status

Completed

Start Date: June 2013

Completed Date:

Phase:

Type: Observational [Patient Registry]

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02045394

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