Smoking-related PathologyPREVALUNG*NCT05649046
Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE
A study testing thoracic scan Low dose, BLOOD SAMPLE and FECES SAMPLE in people with Smoking-related Pathology and Atheroma, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Patients treated at the Hôpital Nord de Marseille for at least one smoking-related pathology (atheroma, chronic bronchitis, non-progressive cancer > 5 years) or with eligibility criteria for lung cancer screening (inclusion criteria in the NLST or NELSON studies or American recommendations) Interventional study with… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Smoking-related Pathology, Atheroma, Chronic Bronchitis
- What is being tested?
- thoracic scan Low dose, BLOOD SAMPLE and FECES SAMPLE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2023to 1 Jun 2024
- Phase
- Interventional
- 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
- Age 45- 75 years and
- Medical follow-up for a smoking-related pathology :
- atheroma
- chronic obstructive pulmonary disease / emphysema
- history of non evolving cancer > 5 years among: ENT, lung, breast, cervical, excreto-urinary cervix, excreto-urinary tract, bladder, esophagus, stomach, pancreas, liver, kidney, chronic myeloid leukemia chronic myeloid leukemia,
- daily smoking for at least 10 years prior to the disease Or
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- NLST inclusion criteria:
- Age 55 - 74 years
- Cumulative smoking ≥ 30 pack-years
- active or quit for less than 15 years Or
- Age 50-75 years
- Smoking:
- > 15 cigarettes/D for more than 25 years or
- > 10 cigarettes /D for more than 30 years
- Active smoking or cessation < 10 years Or
- New American recommendations :
- Age 50 - 80 years
- Smoking ≥20 PA
- Active or weaned <15 years
Who cannot join
- history of cancer < 5 years (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma basal cell carcinoma of the skin and prostate cancer with undetectable PSA)
- Symptoms of lung cancer (unintentional weight loss > 7 kg in 1 year, hemoptysis)
- known history of pulmonary nodule with specialized follow-up
- history of pulmonary fibrosis or pulmonary hypertension
- patient under guardianship or curatorship
- active pulmonary parenchymal infection
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- severe cardiac or respiratory insufficiency (rest dyspnea)
- patient not affiliated to the social security system (beneficiary or beneficiary's right)
- Patient deprived of liberty
- Performance status (WHO) 2, 3 or 4
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Patients treated at the Hôpital Nord de Marseille for at least one smoking-related pathology (atheroma, chronic bronchitis, non-progressive cancer > 5 years) or with eligibility criteria for lung cancer screening (inclusion criteria in the NLST or NELSON studies or American recommendations) Interventional study with minimal risks and constraints, with evaluation of lung cancer prevalence; immunological, blood inflammatory and microbiota profile
Determine the maximum clinical, radiological, and biological phenotyping completeness rate following the implementation of a new lung cancer screening care pathway with multidimensional clinical, radiological, and biological phenotyping capabilities
- Conditions
- Smoking-related Pathology, Atheroma, Chronic Bronchitis, Non-progressive Cancer > 5 Years, Lung Cancer
- Being tested
- thoracic scan Low dose, BLOOD SAMPLE, FECES SAMPLE
- Medical subject headings
- Plaque, Atherosclerotic, Bronchitis, Chronic, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic scan Low doseDevice
within 3 months after the V0 visit
BLOOD SAMPLEBiological
within 3 months after the V0 visit
FECES SAMPLEBiological
within 3 months after the V0 visit
| Study group | Role | What they receive |
|---|---|---|
| patients | Other | Not described Receives: Device: thoracic scan Low dose; Biological: BLOOD SAMPLE; Biological: FECES SAMPLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of complete phenotyping clinical, clinical
Measured: 18 months
number of complete phenotyping radiological
Measured: 18 months
number of complete phenotyping biological samples
Measured: 18 months
Secondary outcomes (9)
Number of lung cancers diagnosed / Number of patients included
Measured: 18 MONTHS
Number of stage ≤ IIB lung cancers / number of lung cancers diagnosed
Measured: 18 MONTHS
Number of patients in partial smoking cessation / number of active smoking patients included
Measured: 18 MONTHS
Satisfaction assessment
by scale SF-12
Measured: 2 times (inclusion, 8 months)
Assessment of ANXIETY
by scale STAI-YA
Measured: 2 times (inclusion, 8 months)
Number of initial positive scans / number of initial scans
Measured: 18 months
Number of invasive procedures resulting in a diagnosis of a benign lesion / number of invasive procedures
Measured: 18 months
Number of cardiovascular events / number of patients included
Measured: 18 months
Number of oncological events (other than lung cancer) / number of patients included
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start23 Jan 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking-related PathologyStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie GARRIDO PRADALIE, Study director, ASSIATANCE PUBLIQUE HOPITAUX DE MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649046
- Sponsor's protocol ID
- RCAPHM22_0184
- Other IDs
- 2022-A01268-35
- Acronym
- PREVALUNG*
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2022
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structuring of a Lung Cancer Screening Program Including Clinical, Radiological and Biological Phenotyping Useful for the Development of Individualized Risk Prediction Tools: PREVALUNG ETOILE
- ClinicalTrials.gov ID
- NCT05649046
- Acronym / sponsor ID
- PREVALUNG* / RCAPHM22_0184
- Conditions
- Smoking-related Pathology, Atheroma, Chronic Bronchitis, Non-progressive Cancer > 5 Years, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 13 Dec 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.
Patients treated at the Hôpital Nord de Marseille for at least one smoking-related pathology (atheroma, chronic bronchitis, non-progressive cancer > 5 years) or with eligibility criteria for lung cancer screening (inclusion criteria in the NLST or NELSON studies or American recommendations) Interventional study with minimal risks and constraints, with evaluation of lung cancer prevalence; immunological, blood inflammatory and microbiota profile
Determine the maximum clinical, radiological, and biological phenotyping completeness rate following the implementation of a new lung cancer screening care pathway with multidimensional clinical, radiological, and biological phenotyping capabilities
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Other | Device: thoracic scan Low dose, Biological: BLOOD SAMPLE, Biological: FECES SAMPLE |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 45- 75 years and
- Medical follow-up for a smoking-related pathology :
- atheroma
- chronic obstructive pulmonary disease / emphysema
- history of non evolving cancer > 5 years among: ENT, lung, breast, cervical, excreto-urinary cervix, excreto-urinary tract, bladder, esophagus, stomach, pancreas, liver, kidney, chronic myeloid leukemia chronic myeloid leukemia,
Key exclusion criteria (11 listed)
- history of cancer < 5 years (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma basal cell carcinoma of the skin and prostate cancer with undetectable PSA)
- Symptoms of lung cancer (unintentional weight loss > 7 kg in 1 year, hemoptysis)
- known history of pulmonary nodule with specialized follow-up
- history of pulmonary fibrosis or pulmonary hypertension
- patient under guardianship or curatorship
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 |
|---|---|---|
| thoracic scan Low dosewithin 3 months after the V0 visit | Device | patients |
| BLOOD SAMPLEwithin 3 months after the V0 visit | Biological | patients |
| FECES SAMPLEwithin 3 months after the V0 visit | Biological | patients |
Primary outcome
number of complete phenotyping clinical, clinical
Time frame: 18 months
number of complete phenotyping radiological
Time frame: 18 months
number of complete phenotyping biological samples
Time frame: 18 months
9 secondary outcomes
Number of lung cancers diagnosed / Number of patients included
Time frame: 18 MONTHS
Number of stage ≤ IIB lung cancers / number of lung cancers diagnosed
Time frame: 18 MONTHS
Number of patients in partial smoking cessation / number of active smoking patients included
Time frame: 18 MONTHS
Satisfaction assessment
Time frame: 2 times (inclusion, 8 months)
Assessment of ANXIETY
Time frame: 2 times (inclusion, 8 months)
Number of initial positive scans / number of initial scans
Time frame: 18 months
Number of invasive procedures resulting in a diagnosis of a benign lesion / number of invasive procedures
Time frame: 18 months
Number of cardiovascular events / number of patients included
Time frame: 18 months
Number of oncological events (other than lung cancer) / number of patients included
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
Related trials for Smoking-related Pathology
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.
Emilie GARRIDO PRADALIE study director
ASSIATANCE PUBLIQUE HOPITAUX DE 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 thoracic scan Low dose, BLOOD SAMPLE and FECES SAMPLE in people with Smoking-related Pathology and Atheroma, run by Assistance Publique Hopitaux De Marseille 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 19 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. 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?
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?
number of complete phenotyping clinical, clinical (time frame: 18 months). The study lists 3 primary outcomes in all. 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 18 Mar 2024; AzTrials last refreshed its copy on 1 Nov 2026.