SmokingNCT05486455
Evaluation of Lung Cancer CT Screening Performance Among Former and Current Smokers
A study testing Low-dose chest CT scan in people with Smoking, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial summary
Diagnostic performance of low-dose chest CT scan combined with lung-RADS classification (version 1.1) for lung cancer screening among former and current smokers. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Smoking
- What is being tested?
- Low-dose chest CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2022to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 50-80 years old
- Active smoker (≥ 15 PA) or former smoker (≥ 15 PA)
Who cannot join
- Recent history of chest CT scan (within 12 months)
- Person unable to climb 2 floors
- Weight > 140kg
- Personal history of cancer < 5 years (currently being monitored by thoracic imaging)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Saint Joseph
Marseille
Cécile BIELMANN, 0033488731070, cbielmann@hopital-saint-joseph.fr
Arnaud Boyer
About this study
Official title: Evaluation of Lung Cancer CT Screening Performance Among Former and Current Smokers: a "Real Life" Study
Diagnostic performance of low-dose chest CT scan combined with lung-RADS classification (version 1.1) for lung cancer screening among former and current smokers.
- Conditions
- Smoking
- Being tested
- Low-dose chest CT scan
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose chest CT scanDiagnostic test
baseline, 1-year, 3-year and 5-year low-dose CT scan
| Study group | Role | What they receive |
|---|---|---|
| CT scan | Experimental | Not described Receives: Diagnostic Test: Low-dose chest CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV)
Measured: 5 years
Secondary outcomes (11)
Sensitivity
Measured: 5 years
Specificity
Measured: 5 years
Early stage lung cancer detection rate (stage I and II)
Measured: 5 years
5-year survival rate of patients who have undergone thoracic surgery
Measured: 5 years
Rate of smoking-related co-morbidities detected on low-dose CT scan
smoking-related co-morbities = pulmonary emphysema, interstitial lung disease, atheromatous disease, hepatic steatosis and ascending aortic aneurysm.
Measured: 5 years
Rate of additional examinations (including invasive diagnostic tests and surgery with benign results)
Measured: 5 years
Risk ratio of lung cancer
Measured: 5 years
Number of false positive results
Measured: 5 years
Penetration rate
number of subjects included / number of includible subjects
Measured: 5 years
Smoking cessation rates
Measured: 5 years
EORTC QLQ-C30 score (version 3)
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions.
The EORTC QLQ-C30 is composed of 9 multi-item scales: 5 functioning scales (physical, role, cognitive, emotional and social), a global QOL scale, and 3 symptom scales (fatigue, pain and nausea/vomiting). In addition, several single item symptom measures are used.
For the five functioning scales and the global quality of life scale, a higher score represents a better level of functioning. For the symptom scales and items, a high score corresponds to a higher level of symptomatology.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start4 Nov 2022
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Boyer, MD, Principal investigator, Hopital Saint Joseph MarseilleIllies Bouabdallah, MD, Study director, Hopital Saint Joseph Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486455
- Sponsor's protocol ID
- DEPITAB
- Status last verified
- Dec 2022
- First submitted
- 1 Aug 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Cancer CT Screening Performance Among Former and Current Smokers: a "Real Life" Study
- ClinicalTrials.gov ID
- NCT05486455
- Acronym / sponsor ID
- DEPITAB
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 3 Aug 2022 (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.
Diagnostic performance of low-dose chest CT scan combined with lung-RADS classification (version 1.1) for lung cancer screening among former and current smokers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT scan | Experimental | Diagnostic Test: Low-dose chest CT scan |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female 50-80 years old
- Active smoker (≥ 15 PA) or former smoker (≥ 15 PA)
Key exclusion criteria (4 listed)
- Recent history of chest CT scan (within 12 months)
- Person unable to climb 2 floors
- Weight > 140kg
- Personal history of cancer < 5 years (currently being monitored by thoracic imaging)
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 |
|---|---|---|
| Low-dose chest CT scanbaseline, 1-year, 3-year and 5-year low-dose CT scan | Diagnostic test | CT scan |
Primary outcome
Positive Predictive Value (PPV)
Time frame: 5 years
11 secondary outcomes
Sensitivity
Time frame: 5 years
Specificity
Time frame: 5 years
Early stage lung cancer detection rate (stage I and II)
Time frame: 5 years
5-year survival rate of patients who have undergone thoracic surgery
Time frame: 5 years
Rate of smoking-related co-morbidities detected on low-dose CT scan
Time frame: 5 years
Rate of additional examinations (including invasive diagnostic tests and surgery with benign results)
Time frame: 5 years
Risk ratio of lung cancer
Time frame: 5 years
Number of false positive results
Time frame: 5 years
Penetration rate
Time frame: 5 years
Smoking cessation rates
Time frame: 5 years
EORTC QLQ-C30 score (version 3)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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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.
Arnaud Boyer, MD principal investigator
Hopital Saint Joseph Marseille
Illies Bouabdallah, MD study director
Hopital Saint Joseph Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose chest CT scan in people with Smoking, run by Hospital St. Joseph, Marseille, France at 1 site in France.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Dec 2022. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cecile Bielmann (0033488731070, cbielman@hopital-saint-joseph.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (PPV) (time frame: 5 years). 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 6 Dec 2022.