Lung CancerPhase 2NCT00321893
Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer
A Phase 2 study testing Budesonide in people with Lung Cancer, run by National Cancer Institute (NCI) at 1 site in Italy.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2006to Sep 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current smokers or former smokers that have stopped within the last 15 years
- Smoking history > 20 pack/years
- Age > 50 years
- Persistent lung nodules detected at Low dose computed tomography (LDCT) scan from previous year with 1 of the following:- longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1 \& 8 mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative PET scan, negative CT enhancement. Nodule should have grown with a doubling time between 1\& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years
- Eastern Cooperative Oncology Group (ECOG) performance status < 1 (Karnofsky >60%)
- Participants must have normal organ and marrow function as defined below: Leukocytes >3,000/mL, absolute neutrophil count greater than 1,500/mL, platelets greater than 100,000/mL, total bilirubin lower than 1.5 * upper normal institutional limits, aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) lower than 1.5 * upper normal institutional limits, creatinine lower than 1.5 * upper normal institutional limits
- Females must be postmenopausal (ie, at least 1 year passed after the last menstruation), surgically sterile, or using acceptable contraceptive measures as judged by the Investigator. (A fertile woman is defined as being of child-bearing potential, from first menstruation to 1 year after last menstruation.). Negative serum beta-HCG for women of childbearing potential will be required at baseline. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- More than 6 lung nodules (suspect of chronic granulomatous disease)
- Lung nodules with clearly benign morphological features at CT scan (i.e, homogenous calcification, solid nodules with regular and round or polygonal margins and distance from the pleura <1cm)
- Subjects currently suffering from malignant disease or having had malignant disease within the last 5 years except for cervical carcinoma in situ and non melanoma skin cancer
- Regular/chronic use of oral or inhaled corticosteroids; regular use being defined as a total of 3 months cumulative use in the last 12 months
- Use of any other investigational agents at time of enrollment in the study during the three months preceding study enrollment
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to corticosteroid
Show all 9Show fewer
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Any other factor that at the investigator's discretion contraindicates the use of inhaled corticosteroids
- Pregnant or lactating females, or females planning to become pregnant during the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If needed, a pregnancy test will be performed on serum during baseline lab test
- HIV-positive or other patients with immunodeficiencies should be excluded because of the risk of infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Trial of Budesonide Turbuhaler® 800 Micrograms/Twice Daily Versus Placebo in High-Risk Population With Undetermined Lung Nodules Detected at Screening Low Dose CT Scan
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules.
PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nodules who are at high risk of lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the effect, in terms of size and number reduction of computed tomography (CT) scan-detected undetermined lung nodules, in asymptomatic subjects with lung nodules at high-risk for developing lung cancer treated with inhaled budesonide vs placebo.
Secondary
- Compare average modification of nodule size and nodule number due to inhaled budesonide versus placebo.
- Correlate the modulation of biological markers of lung cancer in serum and sputum after treatment with the modification of lung nodules sizes.
- Determine treatment toxicity, side effects, and safety of inhaled budesonide.
- Evaluate the role of CT scans in estimating the grade of respiratory impairment and emphysema.
- Determine the effect of inhaled budesonide on respiratory function before and after treatment.
OUTLINE: This is a randomized, double-blind, placebo controlled study.
Participants are stratified according to gender, smoking habit (current vs former smoker), and nodule characteristics (solid vs semisolid or non-solid). Participants are randomized into 1 of 2 treatment arms.
- Arm I: Subjects receive inhaled budesonide twice daily for 1 year in the absence of unacceptable toxicity.
- Arm II: Subjects receive inhaled placebo twice daily for 1 year in the absence of unacceptable toxicity.
Participants undergo blood and sputum collection periodically during study for biomarker and correlative studies.
After completion of study therapy, subjects are followed at 1 month and continue CT scan screening.
PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- Budesonide, Placebo
- Keywords
- Small cell lung cancer, Non-small cell lung cancer, Budesonide, Entocort EC, Pulmicort Respules, Rhinocort aqua, Aerosol budesonide treatment, Smoking
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Also called Entocort EC, Pulmincort Respules, Rhinocort aqua
Inhaled Budesonide 800 micrograms (ug) twice daily for one year.
PlaceboOther
Inhaled placebo twice daily for one year.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Budesonide | Experimental | Inhaled Budesonide 800 ug twice daily for 1 year Receives: Drug: Budesonide |
| Arm II: Placebo | Placebo comparator | Inhaled placebo twice daily for 1 year Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number CT- Detected Lung Nodules by Participant
Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection: Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1\& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1\& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years. Participants followed from baseline to 3 Years, follow up CT assessment planned at 12 months.
Measured: Baseline assessment
Size of CT- Detected Lung Nodules by Participant
Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection. Nodule type categorized as: Nonsolid, Partially Solid, or Solid. Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1\& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1\& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years
Measured: Baseline assessment
Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months
For single nodules >5 mm, clinical meaningful shrinkage of 30% or > longest diameter (LD) considered treatment success after 1 year treatment; for <5 mm, complete disappearance considered treatment success. Multiple lesions success is complete response (CR) or partial response (PR) according to RECIST while failure when progression disease (PD) or stable disease (SD). CR: disappearance all target \& non target lesions + no appearance new lesions; PR: CR for target lesions+incomplete/SD for non target lesions+no new lesions or PR (i.e., 30%<sum LD target lesions) for target lesions + no PD for non target lesions + no appearance of new lesions; PD: PD (at least 20% > sum LD of target lesions) for target lesions irrespective of response of non target lesions or PD for non target lesions irrespective of response for target lesions/or appearance new lesions irrespective of response of target/or non target lesions; SD: neither sufficient shrinkage for PR nor increase for PD.
Measured: 12 Months
Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months
Number of participants with response according to RECIST criteria. For single nodules > 5 mm, clinical meaningful shrinkage of 30% or > of longest diameter (LD) considered treatment success after 1 year of treatment. For single nodules with LD <5 mm, complete disappearance considered treatment success. In case of multiple lesions success of treatment is when complete response (CR) or partial response (PR) occurs according to RECIST criteria.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study startJan 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Giulia Veronesi, MD, Study chair, European Institute of OncologyScott M. Lippman, MD, FACP, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321893
- Sponsor's protocol ID
- NCI-2014-02166
- Other IDs
- MDA-05-5-01, MDA-S262/505, MDA-2005-0953, EUDRACT-2005-004614-32, CDR0000470861, NCI-2012-02113
- Status last verified
- Oct 2014
- First submitted
- 2 May 2006
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fumagalli C, Bianchi F, Raviele PR, Vacirca D, Bertalot G, Rampinelli C, Lazzeroni M, Bonanni B, Veronesi G, Fusco N, Barberis M, Guerini-Rocco E. Circulating and tissue biomarkers in early-stage non-small cell lung cancer. Ecancermedicalscience. 2017 Jan 31;11:717. doi: 10.3332/ecancer.2017.717. eCollection 2017.
PubMed 28194229Veronesi G, Szabo E, Decensi A, Guerrieri-Gonzaga A, Bellomi M, Radice D, Ferretti S, Pelosi G, Lazzeroni M, Serrano D, Lippman SM, Spaggiari L, Nardi-Pantoli A, Harari S, Varricchio C, Bonanni B. Randomized phase II trial of inhaled budesonide versus placebo in high-risk individuals with CT screen-detected lung nodules. Cancer Prev Res (Phila). 2011 Jan;4(1):34-42. doi: 10.1158/1940-6207.CAPR-10-0182. Epub 2010 Dec 16.
PubMed 21163939Lazzeroni M, Guerrieri-Gonzaga A, Serrano D, Varricchio MC, Veronesi G, Radice D, Feroce I, Nardi-Pantoli A, Lippman SM, Szabo E, Bonanni B. Budesonide versus placebo in high-risk population with screen-detected lung nodules: rationale, design and methodology. Contemp Clin Trials. 2010 Nov;31(6):612-9. doi: 10.1016/j.cct.2010.08.006. Epub 2010 Aug 16.
PubMed 20719253
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Budesonide Turbuhaler® 800 Micrograms/Twice Daily Versus Placebo in High-Risk Population With Undetermined Lung Nodules Detected at Screening Low Dose CT Scan
- ClinicalTrials.gov ID
- NCT00321893
- Acronym / sponsor ID
- NCI-2014-02166
- Conditions
- Lung Cancer
- Keywords
- Small cell lung cancer, Non-small cell lung cancer, Budesonide, Entocort EC, Pulmicort Respules, Rhinocort aqua, Aerosol budesonide treatment, Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 4 May 2006 (estimated)
- Results
- Posted 27 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules.
PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nodules who are at high risk of lung cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the effect, in terms of size and number reduction of computed tomography (CT) scan-detected undetermined lung nodules, in asymptomatic subjects with lung nodules at high-risk for developing lung cancer treated with inhaled budesonide vs placebo.
Secondary
- Compare average modification of nodule size and nodule number due to inhaled budesonide versus placebo.
- Correlate the modulation of biological markers of lung cancer in serum and sputum after treatment with the modification of lung nodules sizes.
- Determine treatment toxicity, side effects, and safety of inhaled budesonide.
- Evaluate the role of CT scans in estimating the grade of respiratory impairment and emphysema.
- Determine the effect of inhaled budesonide on respiratory function before and after treatment.
OUTLINE: This is a randomized, double-blind, placebo controlled study.
Participants are stratified according to gender, smoking habit (current vs former smoker), and nodule characteristics (solid vs semisolid or non-solid). Participants are randomized into 1 of 2 treatment arms.
- Arm I: Subjects receive inhaled budesonide twice daily for 1 year in the absence of unacceptable toxicity.
- Arm II: Subjects receive inhaled placebo twice daily for 1 year in the absence of unacceptable toxicity.
Participants undergo blood and sputum collection periodically during study for biomarker and correlative studies.
After completion of study therapy, subjects are followed at 1 month and continue CT scan screening.
PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: Budesonide | Experimental | Drug: BudesonideInhaled Budesonide 800 ug twice daily for 1 year |
| Arm II: Placebo | Placebo comparator | Other: PlaceboInhaled placebo twice daily for 1 year |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Current smokers or former smokers that have stopped within the last 15 years
- Smoking history > 20 pack/years
- Age > 50 years
- Persistent lung nodules detected at Low dose computed tomography (LDCT) scan from previous year with 1 of the following:- longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1 \& 8 mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative PET scan, negative CT enhancement. Nodule should have grown with a doubling time between 1\& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years
- Eastern Cooperative Oncology Group (ECOG) performance status < 1 (Karnofsky >60%)
Key exclusion criteria (9 listed)
- More than 6 lung nodules (suspect of chronic granulomatous disease)
- Lung nodules with clearly benign morphological features at CT scan (i.e, homogenous calcification, solid nodules with regular and round or polygonal margins and distance from the pleura <1cm)
- Subjects currently suffering from malignant disease or having had malignant disease within the last 5 years except for cervical carcinoma in situ and non melanoma skin cancer
- Regular/chronic use of oral or inhaled corticosteroids; regular use being defined as a total of 3 months cumulative use in the last 12 months
- Use of any other investigational agents at time of enrollment in the study during the three months preceding study enrollment
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 |
|---|---|---|
| BudesonideAlso: Entocort EC, Pulmincort Respules, Rhinocort aquaInhaled Budesonide 800 micrograms (ug) twice daily for one year. | Drug | Arm I: Budesonide |
| PlaceboInhaled placebo twice daily for one year. | Other | Arm II: Placebo |
Primary outcome
Number CT- Detected Lung Nodules by Participant
Time frame: Baseline assessment
Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection: Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1\& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1\& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years. Participants followed from baseline to 3 Years, follow up CT assessment planned at 12 months.
Size of CT- Detected Lung Nodules by Participant
Time frame: Baseline assessment
Lung nodules (nodule characteristics) in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria using Computed Tomography (CT) detection. Nodule type categorized as: Nonsolid, Partially Solid, or Solid. Persistent lung nodules detected at CT scan from previous year with 1 of following: longest diameter between 4\&5 mm. Nodules may be stable or grown from the previous year (< 5 mm does not require additional diagnostic follow-up); longest diameter between 5.1\& 8mm. Nodules may be stable or grown from the previous year. If grown, doubling time should be >1 year; longest diameter > 8 mm with negative positron positron emission tomography (PET) scan, negative CT enhancement. Nodule should have grown with doubling time between 1\& 5 years; -longest diameter >8mm, non solid or partially solid nodules, stable or grown with doubling time between 1\&5 years
Number of Participant Overall Responses as Measured by RECIST Criteria at 12 Months
Time frame: 12 Months
For single nodules >5 mm, clinical meaningful shrinkage of 30% or > longest diameter (LD) considered treatment success after 1 year treatment; for <5 mm, complete disappearance considered treatment success. Multiple lesions success is complete response (CR) or partial response (PR) according to RECIST while failure when progression disease (PD) or stable disease (SD). CR: disappearance all target \& non target lesions + no appearance new lesions; PR: CR for target lesions+incomplete/SD for non target lesions+no new lesions or PR (i.e., 30%<sum LD target lesions) for target lesions + no PD for non target lesions + no appearance of new lesions; PD: PD (at least 20% > sum LD of target lesions) for target lesions irrespective of response of non target lesions or PD for non target lesions irrespective of response for target lesions/or appearance new lesions irrespective of response of target/or non target lesions; SD: neither sufficient shrinkage for PR nor increase for PD.
Participant Overall Response (by Tumor Type Subsolid or Solid Tumor) as Measured by RECIST Criteria at 12 Months
Time frame: 12 Months
Number of participants with response according to RECIST criteria. For single nodules > 5 mm, clinical meaningful shrinkage of 30% or > of longest diameter (LD) considered treatment success after 1 year of treatment. For single nodules with LD <5 mm, complete disappearance considered treatment success. In case of multiple lesions success of treatment is when complete response (CR) or partial response (PR) occurs according to RECIST criteria.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28194229Fumagalli C, Bianchi F, Raviele PR, Vacirca D, Bertalot G, Rampinelli C, Lazzeroni M, Bonanni B, Veronesi G, Fusco N, Barberis M, Guerini-Rocco E. Circulating and tissue biomarkers in early-stage non-small cell lung cancer. Ecancermedicalscience. 2017 Jan 31;11:717. doi: 10.3332/ecancer.2017.717. eCollection 2017.
- Derived from this study: PubMed 21163939Veronesi G, Szabo E, Decensi A, Guerrieri-Gonzaga A, Bellomi M, Radice D, Ferretti S, Pelosi G, Lazzeroni M, Serrano D, Lippman SM, Spaggiari L, Nardi-Pantoli A, Harari S, Varricchio C, Bonanni B. Randomized phase II trial of inhaled budesonide versus placebo in high-risk individuals with CT screen-detected lung nodules. Cancer Prev Res (Phila). 2011 Jan;4(1):34-42. doi: 10.1158/1940-6207.CAPR-10-0182. Epub 2010 Dec 16.
- Derived from this study: PubMed 20719253Lazzeroni M, Guerrieri-Gonzaga A, Serrano D, Varricchio MC, Veronesi G, Radice D, Feroce I, Nardi-Pantoli A, Lippman SM, Szabo E, Bonanni B. Budesonide versus placebo in high-risk population with screen-detected lung nodules: rationale, design and methodology. Contemp Clin Trials. 2010 Nov;31(6):612-9. doi: 10.1016/j.cct.2010.08.006. Epub 2010 Aug 16.
- University of Texas (UT) MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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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.
Giulia Veronesi, MD study chair
European Institute of Oncology
Scott M. Lippman, MD, FACP study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Budesonide in people with Lung Cancer, run by National Cancer Institute (NCI) at 1 site 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 8 inclusion and 9 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 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number CT- Detected Lung Nodules by Participant (time frame: Baseline assessment). The study lists 4 primary outcomes in all. 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 NCT00321893, 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 25 Jan 2016.