Lung CancerNCT02045394
Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study
An observational study of Lung Cancer and Tuberculosis, run by University of Milan at 6 sites in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Tuberculosis, Bronchiectasis
- What is being tested?
- Chest X-ray, computed tomography of the chest and Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 610 participants
- Where
- 6 sitesItaly
- Study dates
- Jun 2013to Oct 2015
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients and outpatients with haemoptysis requiring a diagnosis referred for medical consultation to italian university and clinical hospitals.
Who may be able to join
- haemoptysis requiring a diagnosis
Who cannot join
- history of known bleeding lesions in the upper or lower airways
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Pneumologia, Azienda Ospedaliero Universitaria
Ancona
USC Pneumologia, Azienda Ospedaliera della Provincia di Lodi
Lodi
U.O. di Pnuemologia, Azienda Ospedaliera, Carlo Poma
Mantua
Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano.
Milan, 20142
A.O.U. Maggiore della Carità - S.C.D.O. Pneumologia
Novara
Clinica Pneumotisiologica, AOU Sassari
Sassari
About this study
Official title: Multicenter, Prospective, Observational Study on Epidemiology and Diagnosis of Haemoptysis
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
- Lung Cancer, Tuberculosis, Bronchiectasis, Pneumonia, Acute Bronchitis, Chronic Obstructive Pulmonary Disease
- Being tested
- Chest X-ray, computed tomography of the chest, Bronchoscopy
- Keywords
- haemoptysis, hemoptysis, airway bleeding
- Medical subject headings
- Lung Neoplasms, Tuberculosis, Bronchiectasis, Pneumonia, Bronchitis, Pulmonary Disease, Chronic Obstructive, Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest X-rayOther
computed tomography of the chestOther
Also called chest CT scan
BronchoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting with haemoptysis | Not described Receives: Other: Chest X-ray; Other: computed tomography of the chest; Procedure: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18 months
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 610 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabiano Di Marco, University of Milan
- Investigators
- Michele Mondoni, MD, Principal investigator, Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.Paolo Carlucci, MD, Study chair, Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.Stefano Centanni, MD, PhD, Study director, Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045394
- Sponsor's protocol ID
- HAEMOPTYSIS76
- Status last verified
- Dec 2015
- First submitted
- 13 Jan 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mondoni 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.
PubMed 34348724Mondoni 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.
PubMed 30744616Mondoni 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.
PubMed 29301924
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Observational Study on Epidemiology and Diagnosis of Haemoptysis
- ClinicalTrials.gov ID
- NCT02045394
- Acronym / sponsor ID
- HAEMOPTYSIS76
- Conditions
- Lung Cancer, Tuberculosis, Bronchiectasis, Pneumonia, Acute Bronchitis, Chronic Obstructive Pulmonary Disease
- Keywords
- haemoptysis, hemoptysis, airway bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2015 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting with haemoptysis | – | Other: Chest X-ray, Other: computed tomography of the chest, Procedure: Bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients and outpatients with haemoptysis requiring a diagnosis referred for medical consultation to italian university and clinical hospitals.
Key inclusion criteria (1 listed)
- haemoptysis requiring a diagnosis
Key exclusion criteria (1 listed)
- history of known bleeding lesions in the upper or lower airways
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest X-ray | Other | Patients presenting with haemoptysis |
| computed tomography of the chestAlso: chest CT scan | Other | Patients presenting with haemoptysis |
| 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. | Procedure or surgery | Patients presenting with haemoptysis |
Primary outcome
Percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes.
Time frame: 18 months
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).
4 secondary outcomes
Sensitivity and specificity of chest X-ray, chest CT scan and bronchoscopy alone and in combination in the diagnosis of different causes of haemoptysis.
Time frame: 18 months
Percentage and severity of recurrence of haemoptysis in the follow-up period.
Time frame: 18 months
Sensitivity and specificity of bronchoscopy in localizing the bleeding side and lobe in relation to the timing of the haemoptysis.
Time frame: 18 months
Patient survival in the follow-up period.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Derived from this study: PubMed 34348724Mondoni 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.
- Derived from this study: PubMed 30744616Mondoni 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.
- Derived from this study: PubMed 29301924Mondoni 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.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Mondoni, MD principal investigator
Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
Paolo Carlucci, MD study chair
Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
Stefano Centanni, MD, PhD study director
Respiratory Unit, San Paolo Hospital, Dipartimento Scienze della Salute, Università degli Studi di Milano, Milan, Italy.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Tuberculosis, run by University of Milan at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients presenting with haemoptysis affected by lung cancer, tuberculosis, bronchiectasis, pneumonia, acute bronchitis, cryptogenic haemoptysis or other causes. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045394, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.