Clinical trial · Observational
Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study
Multicenter, Prospective, Observational Study on Epidemiology and Diagnosis of Haemoptysis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Bronchitis | — | UNRESOLVED | — |
| Bronchiectasis | — | UNRESOLVED | — |
| Chronic Obstructive Pulmonary Disease | — | UNRESOLVED | — |
| Cryptogenic Haemoptysis | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pneumonia | — | UNRESOLVED | — |
| Tuberculosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bronchoscopy | Procedure | — | UNRESOLVED |
| Chest X-ray | Other | — | UNRESOLVED |
| computed tomography of the chest | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients presenting with haemoptysis
- interventionNames
- Other: Chest X-ray
- Other: computed tomography of the chest
- Procedure: Bronchoscopy
Primary outcomes (1)
- measure
- Percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes.
- timeFrame
- 18 months
- description
- 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).
Secondary outcomes (4)
- measure
- Sensitivity and specificity of chest X-ray, chest CT scan and bronchoscopy alone and in combination in the diagnosis of different causes of haemoptysis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * haemoptysis requiring a diagnosis Exclusion Criteria: * history of known bleeding lesions in the upper or lower airways
References
Publications (3)
- DERIVEDMondoni M, Carlucci P, Cipolla G, Pagani M, Tursi F, Fois A, Pirina P, Canu S, Gasparini S, Bonifazi M, Marani S, Comel A, Saderi L, De Pascalis S, Alfano F, Centanni S, Sotgiu G. Long-term prognostic outcomes in patients with haemoptysis. Respir Res. 2021 Aug 4;22(1):219. doi: 10.1186/s12931-021-01809-6. PMID 34348724
- DERIVEDMondoni M, Carlucci P, Cipolla G, Fois A, Gasparini S, Marani S, Centanni S, Sotgiu G. Bronchoscopy to assess patients with hemoptysis: which is the optimal timing? BMC Pulm Med. 2019 Feb 11;19(1):36. doi: 10.1186/s12890-019-0795-9. PMID 30744616
- DERIVEDMondoni M, Carlucci P, Job S, Parazzini EM, Cipolla G, Pagani M, Tursi F, Negri L, Fois A, Canu S, Arcadu A, Pirina P, Bonifazi M, Gasparini S, Marani S, Comel AC, Ravenna F, Dore S, Alfano F, Sferrazza Papa GF, Di Marco F, Centanni S, Sotgiu G. Observational, multicentre study on the epidemiology of haemoptysis. Eur Respir J. 2018 Jan 4;51(1):1701813. doi: 10.1183/13993003.01813-2017. Print 2018 Jan. No abstract available. PMID 29301924