Lung CancerNCT01540552
Natural History of Lung Nodules Seen on CT Scans From Participants at High-Risk of Developing Lung Cancer
An observational study of Lung Cancer and Precancerous Condition, run by M.D. Anderson Cancer Center at 1 site in Italy.
Trial summary
RATIONALE: Comparing lung CT scans from participants with lung nodules at high-risk for lung cancer may help doctors learn more about the disease and find better methods of treatment. PURPOSE: This trial studies the natural history of lung nodules using CT scans from participants at high-risk for lung cancer. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lung Cancer, Precancerous Condition
- What is being tested?
- medical chart review, computed tomography and computer-aided detection/diagnosis
- Type of treatment
- Surgery or procedure
- How many people
- 320 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2012to Jan 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants previously enrolled in two trials: (1) a large scale COSMOS trial and (2) a subset of the COSMOS trial (MDA05-5-01 Budesonide study and treated for one year). Only participants enrolled in both trials will be included.
DISEASE CHARACTERISTICS:
- Annual Computed Tomography (CT) scans obtained from participants with undetermined lung nodules detected by low-dose CT enrolled in both of the following trials:
- A large-scale COSMOS screening trial
- Three annual CT scans obtained as part of the COSMOS trial after budesonide study treatment completion
- The MDA05-5-01, a subset of COSMOS trial participants, a randomized phase II trial of inhaled budesonide twice daily versus placebo
- Two CT scans performed as part of the budesonide protocol (MDA05-5-01)
- Only CT scans from participants enrolled in both trials will be used
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Undetermined Ld-CT Detected Lung Nodules Among a Randomized Phase II Trial With Inhaled Budesonide
RATIONALE: Comparing lung CT scans from participants with lung nodules at high-risk for lung cancer may help doctors learn more about the disease and find better methods of treatment.
PURPOSE: This trial studies the natural history of lung nodules using CT scans from participants at high-risk for lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluation of lung nodules (target and non-target lesions) detected during annual low-dose (ld) computed tomography (CT) scans and measured for three years after study completion in subjects enrolled in a randomized, phase IIb, placebo-controlled trial with inhaled budesonide (both person-specific and lesion-specific analyses will be performed).
Secondary
- Lung cancer detection rate in the two arms.
- Appearance of new nodules in the two arms.
OUTLINE: Low-dose CT scans are analyzed retrospectively for the natural progression of undetermined lung nodules. Nodule dimension will be evaluated according to maximum diameter and volume, when feasible. Volume measurements are performed using an automatic and semi-automatic computer-aided diagnosis (CAD) system. Lesion-specific and person-specific analysis are performed by measure of average change in size of the target lesions or number of lesions.
- Conditions
- Lung Cancer, Precancerous Condition
- Being tested
- medical chart review, computed tomography, computer-aided detection/diagnosis
- Keywords
- lung cancer, precancerous condition, lung nodules, CT Scan
- Medical subject headings
- Lung Neoplasms, Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
computed tomographyProcedure or surgery
computer-aided detection/diagnosisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Budesonide Arm | Retrospective Medical Chart Review of low dose CT scans for participants who received Budesonide. Receives: Other: medical chart review; Procedure: computed tomography; Procedure: computer-aided detection/diagnosis | |
| Placebo Arm | Retrospective Medical Chart Review of low dose CT scans for participants who received Placebo. Receives: Other: medical chart review; Procedure: computed tomography; Procedure: computer-aided detection/diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural evolution of lung nodules
Measured: 5 year review period
Secondary outcomes (2)
Lung cancer detection rate
Measured: 5 year review period
Appearance of new nodules
Measured: 5 year review period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Powel H. Brown, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540552
- Sponsor's protocol ID
- PA11-1128
- Other IDs
- MDA-MDA05-5-03, CDR0000726610
- Status last verified
- Jan 2013
- First submitted
- 22 Feb 2012
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Veronesi G, Lazzeroni M, Szabo E, Brown PH, DeCensi A, Guerrieri-Gonzaga A, Bellomi M, Radice D, Grimaldi MC, Spaggiari L, Bonanni B. Long-term effects of inhaled budesonide on screening-detected lung nodules. Ann Oncol. 2015 May;26(5):1025-1030. doi: 10.1093/annonc/mdv064. Epub 2015 Feb 11.
PubMed 25672894
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Undetermined Ld-CT Detected Lung Nodules Among a Randomized Phase II Trial With Inhaled Budesonide
- ClinicalTrials.gov ID
- NCT01540552
- Acronym / sponsor ID
- PA11-1128
- Conditions
- Lung Cancer, Precancerous Condition
- Keywords
- lung cancer, precancerous condition, lung nodules, CT Scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Feb 2012 (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.
RATIONALE: Comparing lung CT scans from participants with lung nodules at high-risk for lung cancer may help doctors learn more about the disease and find better methods of treatment.
PURPOSE: This trial studies the natural history of lung nodules using CT scans from participants at high-risk for lung cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluation of lung nodules (target and non-target lesions) detected during annual low-dose (ld) computed tomography (CT) scans and measured for three years after study completion in subjects enrolled in a randomized, phase IIb, placebo-controlled trial with inhaled budesonide (both person-specific and lesion-specific analyses will be performed).
Secondary
- Lung cancer detection rate in the two arms.
- Appearance of new nodules in the two arms.
OUTLINE: Low-dose CT scans are analyzed retrospectively for the natural progression of undetermined lung nodules. Nodule dimension will be evaluated according to maximum diameter and volume, when feasible. Volume measurements are performed using an automatic and semi-automatic computer-aided diagnosis (CAD) system. Lesion-specific and person-specific analysis are performed by measure of average change in size of the target lesions or number of lesions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide Arm | – | Other: medical chart review, Procedure: computed tomography, Procedure: computer-aided detection/diagnosisRetrospective Medical Chart Review of low dose CT scans for participants who received Budesonide. |
| Placebo Arm | – | Other: medical chart review, Procedure: computed tomography, Procedure: computer-aided detection/diagnosisRetrospective Medical Chart Review of low dose CT scans for participants who received Placebo. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants previously enrolled in two trials: (1) a large scale COSMOS trial and (2) a subset of the COSMOS trial (MDA05-5-01 Budesonide study and treated for one year). Only participants enrolled in both trials will be included.
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 |
|---|---|---|
| medical chart review | Other | Budesonide Arm, Placebo Arm |
| computed tomography | Procedure or surgery | Budesonide Arm, Placebo Arm |
| computer-aided detection/diagnosis | Procedure or surgery | Budesonide Arm, Placebo Arm |
Primary outcome
Natural evolution of lung nodules
Time frame: 5 year review period
2 secondary outcomes
Lung cancer detection rate
Time frame: 5 year review period
Appearance of new nodules
Time frame: 5 year review period
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 25 Jan 2013.
- Derived from this study: PubMed 25672894Veronesi G, Lazzeroni M, Szabo E, Brown PH, DeCensi A, Guerrieri-Gonzaga A, Bellomi M, Radice D, Grimaldi MC, Spaggiari L, Bonanni B. Long-term effects of inhaled budesonide on screening-detected lung nodules. Ann Oncol. 2015 May;26(5):1025-1030. doi: 10.1093/annonc/mdv064. Epub 2015 Feb 11.
- University of Texas MD Anderson Cancer CenterLink provided by the sponsor.
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.
Powel H. Brown, MD, PhD principal investigator
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?
An observational study of Lung Cancer and Precancerous Condition, run by M.D. Anderson Cancer Center 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?
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 2013. 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. 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?
Natural evolution of lung nodules (time frame: 5 year review period). 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 NCT01540552, which also lists 1 linked publication.
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 2013.