Lung CancerNCT01799395
Prevalence and Incidence of Central Airway Obstruction in Advanced Lung Cancer
An observational study of Lung Cancer, run by Maggiore Bellaria Hospital, Bologna at 5 sites in Italy.
Trial summary
Lung cancer may cause central airway obstruction through several different mechanisms (invasion by the primary tumor, invasion by metastatic lymph nodes, airway metastasis). The aim of the present study is to determine the prevalence at the time of diagnosis, the incidence at 1 year from the diagnosis, and the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer
- How many people
- 45 participants
- Where
- 5 sitesItaly
- Study dates
- Feb 2013to Mar 2015
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced lung cancer undergoing treatment and follow-up at the Oncology Units of the Azienda USL di Bologna (government structure that manages several public hospitals that "cover" a 800.000 inhabitants area)
Who may be able to join
- Advanced lung cancer with indication for chemotherapy or chemotherapy + radiation therapy
Who cannot join
- Age < 18 year
- Pregnancy
- Refusal to sign informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Bentivoglio Hospital
Bentivoglio, Emilia-Romagna, 40010
Bellaria Hospital
Bologna, Emilia-Romagna, 40100
Maggiore Hospital
Bologna, Emilia-Romagna, 4013
Budrio Hospital
Budrio, Emilia-Romagna, 40054
SS Salvatore Hospital
San Giovanni in Persiceto, Emilia-Romagna, 40017
About this study
Official title: Prevalence, Incidence and Predictors of Central Airway Obstruction in Patients With Advanced Lung Cancer
Lung cancer may cause central airway obstruction through several different mechanisms (invasion by the primary tumor, invasion by metastatic lymph nodes, airway metastasis).
The aim of the present study is to determine the prevalence at the time of diagnosis, the incidence at 1 year from the diagnosis, and the predictors of central airway obstruction associated with advanced lung cancer.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer | All patients with advanced lung cancer candidate for chemotherapy or chemotherapy + radiation therapy will be enrolled and followed-up for 1 year clinically and radiologically (Chest CT) to verify whether or not central airway obstruction is present at the time of diagnosis or occurs in the year following diagnosis (or in the life span from diagnosis and death in patients who die before 1 year of diagnosis). Furthermore, predictor variables possibly associated with central airway obstruction will be studied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of central airway obstruction
The incidence will be measured over a 12 month period after diagnosis (or over the life span from diagnosis to death in patients who die before 1 year from the diagnosis)
Measured: 12 months
Secondary outcomes (2)
Predictor variables associated with the presence/occurrence of central airway obstruction
Measured: 12 months
Prevalence of central airway obstruction
The prevalence of central airway obstruction will be evaluated at the time of diagnosis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Staff constraints made it impossibile to enroll consecutive patients, making the sample not representative of the true cancer population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maggiore Bellaria Hospital, Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocco Trisolini, Maggiore Bellaria Hospital, Bologna
- Investigators
- Rocco Trisolini, M.D., Principal investigator, Maggiore Bellaria Hospital, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799395
- Sponsor's protocol ID
- 13002-Trisolini
- Status last verified
- Sep 2017
- First submitted
- 23 Feb 2013
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Incidence and Predictors of Central Airway Obstruction in Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT01799395
- Acronym / sponsor ID
- 13002-Trisolini
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Staff constraints made it impossibile to enroll consecutive patients, making the sample not representative of the true cancer population
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Maggiore Bellaria Hospital, BolognaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 26 Feb 2013 (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.
Lung cancer may cause central airway obstruction through several different mechanisms (invasion by the primary tumor, invasion by metastatic lymph nodes, airway metastasis).
The aim of the present study is to determine the prevalence at the time of diagnosis, the incidence at 1 year from the diagnosis, and the predictors of central airway obstruction associated with advanced lung cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer | – | –All patients with advanced lung cancer candidate for chemotherapy or chemotherapy + radiation therapy will be enrolled and followed-up for 1 year clinically and radiologically (Chest CT) to verify whether or not central airway obstruction is present at the time of diagnosis or occurs in the year following diagnosis (or in the life span from diagnosis and death in patients who die before 1 year of diagnosis). Furthermore, predictor variables possibly associated with central airway obstruction will be studied. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced lung cancer undergoing treatment and follow-up at the Oncology Units of the Azienda USL di Bologna (government structure that manages several public hospitals that "cover" a 800.000 inhabitants area)
Key inclusion criteria (1 listed)
- Advanced lung cancer with indication for chemotherapy or chemotherapy + radiation therapy
Key exclusion criteria (3 listed)
- Age < 18 year
- Pregnancy
- Refusal to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of central airway obstruction
Time frame: 12 months
The incidence will be measured over a 12 month period after diagnosis (or over the life span from diagnosis to death in patients who die before 1 year from the diagnosis)
2 secondary outcomes
Predictor variables associated with the presence/occurrence of central airway obstruction
Time frame: 12 months
Prevalence of central airway obstruction
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Staff constraints made it impossibile to enroll consecutive patients, making the sample not representative of the true cancer population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
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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.
Rocco Trisolini, M.D. principal investigator
Maggiore Bellaria Hospital, Bologna, Italy
5 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, run by Maggiore Bellaria Hospital, Bologna at 5 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 3 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: stopped early, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 was stopped early (reason given: Staff constraints made it impossibile to enroll consecutive patients, making the sample not representative of the true cancer population). Results are not available in the source record.
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?
Incidence of central airway obstruction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2017.