Lung CancerPhase 3SOS2NCT03645018
Lung Cancer Early Diagnosis With Digital Tomosynthesis: Re-evaluation of Lung Nodule Detection Rate at 5 Years
A Phase 3 study testing diagnosis with tomosynthesis in people with Lung Cancer, run by Ospedale Santa Croce-Carle Cuneo at 1 site in Italy.
Trial summary
Lung cancer is the leading cause of cancer-related death around the world, it represents 13% of all new cancer diagnoses. The lung cancer incidence is gradually increasing, especially among women and young people, but the fraction of cured patient remains low. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- diagnosis with tomosynthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,341 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2017to 31 Aug 2018
- Phase
- Phase 3
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current or former smoker status;
- for former smokers, the maximum time since quitting smoking must be below 10 years;
- smoking history of at least 20 pack-years;
- age 45-80 years;
- no previous history of cancer in the 10 years before the beginning of the study;
- be able to stand and hold the breath for 11 seconds during image acquisition;
- previous participation to SOS trial.
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Monocenter Prospective No-profit Interventional Study for Lung Cancer Early Diagnosis With Tomosynthesis: Re-evaluation of Lung Nodule Detection Rate at 5 Years
Lung cancer is the leading cause of cancer-related death around the world, it represents 13% of all new cancer diagnoses. The lung cancer incidence is gradually increasing, especially among women and young people, but the fraction of cured patient remains low. In 80% of cases lung cancer, in early phase, is treatable only with surgery without chemotherapy or adjuvant radiotherapy and the survival perspective at five years exceeds 70%. Several scientific guidelines recommends chest CT (computed tomography) in lung cancer screening. Digital tomosynthesis (DTS) is a limited angle tomography that allows reconstruction of coronal images from a set of projection acquired over a small angle of X-ray tube movement. Several studies demonstrates that DTS is a reasonable alternative to the CT and allows a better evaluation of suspects nodules compared to conventional chest RX.
Read the detailed description
Lung cancer is the leading cause of cancer-related death around the world. In 2008 there were nearly 1.6 million new cases worldwide, accounting for the 12.7% of all new cancer diagnoses. Despite decreasing trends in smoking and resulting decrease in lung cancer mortality, the population at risk for lung cancer continues to be large. In the past years several programs have been developed to screen for lung cancer using low-dose chest computed radiography (CT). However, only recently different studies demonstrated a clear reduction in mortality. In particular, NLST low dose CT screening trial demonstrated a 6.7% reduction in the death rate compared to chest X-ray with a positive screening test rate for lung cancer detection of 24.2%, compared to 6.9% for conventional X-ray. Digital tomosynthesis (DTS) is a limited angle tomography that allows reconstruction of multiple image planes from a set of projection data acquired over a relatively small angle of X-ray tube movement. Although it does not have the spatial depth resolution of computed tomography, it provides high-resolution images in the sagittal planes at a lower dose and cost than CT. Several studies have shown that DTS offers advantages over conventional chest X-ray and comparable of those of CT. The Studio OSservazionale (SOS) was a clinical trial conducted within Santa Croce e Carle Hospital analysing smokers and former smokers aged 45-80 with no cancer diagnosis. All the subjects in whom a suspicious nodule was detected by DTS underwent diagnostic CT. The SOS study demonstrated that baseline DTS detected pulmonary abnormalities in 14.5% and lung cancer in 1.0% of the subjects, comparable to results that are obtained in CT screening programs. A second DTS, within the same study, executed one year later reported pulmonary abnormalities in 0.7% and lung cancer in 0.3% of the subjects.
- Conditions
- Lung Cancer
- Being tested
- diagnosis with tomosynthesis
- Keywords
- lung, cancer, early diagnosis, DTS
- Medical subject headings
- Lung Neoplasms, Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis with tomosynthesisDiagnostic test
Re-evaluation of lung nodule detection rate at 5 years in patients with early diagnosis of lung cancer
| Study group | Role | What they receive |
|---|---|---|
| diagnosis with tomosynthesis (DTS) | Experimental | Single arm.
Population: Subjects enrolled in previously closed SOS trial (high risk subjects for lung cancer) without confirmed lung cancer. Receives: Diagnostic Test: diagnosis with tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the lung cancer detection rate in the population of high risks subjects previously enrolled in lung cancer screening trial with chest digital tomosynthesis (SOS trial).
Lung cancer detection rate (primary endpoint)
Measured: 1 year
Secondary outcomes (5)
Percentage of lung cancer addressed to radical surgery treatment
Measured: 1 year
Sensitivity of DTS evaluating the number of lung cancer occurred in the population of SOS study in the last 5 years
Measured: 1 year
Mortality
Measured: 1 year
OS
Overall survival
Measured: 1 year
QoL: quality of life: Percentage of partecipants changing their smoking habits
Percentage of partecipants changing their smoking habits after trial
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Sep 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocenter prospective no-profit single group interventional study.
- Masking
- None (open label)
- Enrolment
- 1,341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Croce-Carle Cuneo
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione CRC - Cuneo, University of Turin, Italy
- Responsible party
- Principal investigator, MAURIZIO GROSSO, Ospedale Santa Croce-Carle Cuneo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645018
- Sponsor's protocol ID
- SOS2
- Acronym
- SOS2
- Status last verified
- Sep 2018
- First submitted
- 20 Jul 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Terzi A, Bertolaccini L, Viti A, Comello L, Ghirardo D, Priotto R, Grosso M; SOS Study Group. Lung cancer detection with digital chest tomosynthesis: baseline results from the observational study SOS. J Thorac Oncol. 2013 Jun;8(6):685-92. doi: 10.1097/JTO.0b013e318292bdef.
PubMed 23612466Bertolaccini L, Viti A, Tavella C, Priotto R, Ghirardo D, Grosso M, Terzi A; SOS Study Group. Lung cancer detection with digital chest tomosynthesis: first round results from the SOS observational study. Ann Transl Med. 2015 Apr;3(5):67. doi: 10.3978/j.issn.2305-5839.2015.03.41.
PubMed 25992366
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocenter Prospective No-profit Interventional Study for Lung Cancer Early Diagnosis With Tomosynthesis: Re-evaluation of Lung Nodule Detection Rate at 5 Years
- ClinicalTrials.gov ID
- NCT03645018
- Acronym / sponsor ID
- SOS2 / SOS2
- Conditions
- Lung Cancer
- Keywords
- lung, cancer, early diagnosis, DTS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,341 participants (actual)
- Lead sponsor
- Ospedale Santa Croce-Carle CuneoUniversity, hospital or other
- Collaborators
- Fondazione CRC - Cuneo, University of Turin, Italy
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 24 Aug 2018 (actual)
- 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 is the leading cause of cancer-related death around the world, it represents 13% of all new cancer diagnoses. The lung cancer incidence is gradually increasing, especially among women and young people, but the fraction of cured patient remains low. In 80% of cases lung cancer, in early phase, is treatable only with surgery without chemotherapy or adjuvant radiotherapy and the survival perspective at five years exceeds 70%. Several scientific guidelines recommends chest CT (computed tomography) in lung cancer screening. Digital tomosynthesis (DTS) is a limited angle tomography that allows reconstruction of coronal images from a set of projection acquired over a small angle of X-ray tube movement. Several studies demonstrates that DTS is a reasonable alternative to the CT and allows a better evaluation of suspects nodules compared to conventional chest RX.
Detailed description
Lung cancer is the leading cause of cancer-related death around the world. In 2008 there were nearly 1.6 million new cases worldwide, accounting for the 12.7% of all new cancer diagnoses. Despite decreasing trends in smoking and resulting decrease in lung cancer mortality, the population at risk for lung cancer continues to be large. In the past years several programs have been developed to screen for lung cancer using low-dose chest computed radiography (CT). However, only recently different studies demonstrated a clear reduction in mortality. In particular, NLST low dose CT screening trial demonstrated a 6.7% reduction in the death rate compared to chest X-ray with a positive screening test rate for lung cancer detection of 24.2%, compared to 6.9% for conventional X-ray. Digital tomosynthesis (DTS) is a limited angle tomography that allows reconstruction of multiple image planes from a set of projection data acquired over a relatively small angle of X-ray tube movement. Although it does not have the spatial depth resolution of computed tomography, it provides high-resolution images in the sagittal planes at a lower dose and cost than CT. Several studies have shown that DTS offers advantages over conventional chest X-ray and comparable of those of CT. The Studio OSservazionale (SOS) was a clinical trial conducted within Santa Croce e Carle Hospital analysing smokers and former smokers aged 45-80 with no cancer diagnosis. All the subjects in whom a suspicious nodule was detected by DTS underwent diagnostic CT. The SOS study demonstrated that baseline DTS detected pulmonary abnormalities in 14.5% and lung cancer in 1.0% of the subjects, comparable to results that are obtained in CT screening programs. A second DTS, within the same study, executed one year later reported pulmonary abnormalities in 0.7% and lung cancer in 0.3% of the subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocenter prospective no-profit single group interventional study.
| Arm | Type | Receives |
|---|---|---|
| diagnosis with tomosynthesis (DTS) | Experimental | Diagnostic Test: diagnosis with tomosynthesisSingle arm. Population: Subjects enrolled in previously closed SOS trial (high risk subjects for lung cancer) without confirmed lung cancer. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- current or former smoker status;
- for former smokers, the maximum time since quitting smoking must be below 10 years;
- smoking history of at least 20 pack-years;
- age 45-80 years;
- no previous history of cancer in the 10 years before the beginning of the study;
Key exclusion criteria (1 listed)
- pregnancy
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 |
|---|---|---|
| diagnosis with tomosynthesisRe-evaluation of lung nodule detection rate at 5 years in patients with early diagnosis of lung cancer | Diagnostic test | diagnosis with tomosynthesis (DTS) |
Primary outcome
To evaluate the lung cancer detection rate in the population of high risks subjects previously enrolled in lung cancer screening trial with chest digital tomosynthesis (SOS trial).
Time frame: 1 year
Lung cancer detection rate (primary endpoint)
5 secondary outcomes
Percentage of lung cancer addressed to radical surgery treatment
Time frame: 1 year
Sensitivity of DTS evaluating the number of lung cancer occurred in the population of SOS study in the last 5 years
Time frame: 1 year
Mortality
Time frame: 1 year
OS
Time frame: 1 year
QoL: quality of life: Percentage of partecipants changing their smoking habits
Time frame: 1 year
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 14 Sep 2018.
- Results publication: PubMed 23612466Terzi A, Bertolaccini L, Viti A, Comello L, Ghirardo D, Priotto R, Grosso M; SOS Study Group. Lung cancer detection with digital chest tomosynthesis: baseline results from the observational study SOS. J Thorac Oncol. 2013 Jun;8(6):685-92. doi: 10.1097/JTO.0b013e318292bdef.
- Results publication: PubMed 25992366Bertolaccini L, Viti A, Tavella C, Priotto R, Ghirardo D, Grosso M, Terzi A; SOS Study Group. Lung cancer detection with digital chest tomosynthesis: first round results from the SOS observational study. Ann Transl Med. 2015 Apr;3(5):67. doi: 10.3978/j.issn.2305-5839.2015.03.41.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing diagnosis with tomosynthesis in people with Lung Cancer, run by Ospedale Santa Croce-Carle Cuneo 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 7 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 14 Sep 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To evaluate the lung cancer detection rate in the population of high risks subjects previously enrolled in lung cancer screening trial with chest digital tomosynthesis (SOS trial). (time frame: 1 year). 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 NCT03645018, which also lists 2 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 14 Sep 2018.