TobaccoDETeCTORNCT02849041
Screening of Tobacco-induced Cancers by Low-dose CT-scanner and Identification of Circulating Tumor Cells
A study testing medical imaging, Identification of Circulating Tumor Cells and Psychological Questionnaires in people with Tobacco and Cancer, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Tobacco smoke is the most common source of exposure to carcinogens in humans. Indeed, the smoke contains about 1010 particles per ml and 4800 chemical compounds, at least 66 are carcinogenic. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- What is being tested?
- medical imaging, Identification of Circulating Tumor Cells and Psychological Questionnaires
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jan 2017to 23 Dec 2023
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with at least a cumulative smoking 30 pack-years,
- Active or weaned smoking since less than 15 years,
- Who consults or is hospitalized in a medical services or vascular surgery 'Paris Saint Joseph Hospital Group' (GHPSJ) or 'the European Hospital Georges Pompidou' (HEGP) for occlusive arterial disease or aneurysm the abdominal aorta,
- Accepting the repeat CT scans and blood tests, as provided for by the protocol and additional investigations which might be necessitated by the detection of abnormality (s) to previous reviews,
- Accepting, in case of continuing active smoking, engage in smoking cessation process.
Who cannot join
- Bronchial history of cancer,
- Diagnosis and / or previous treatment of another cancer within 5 years prior to study entry, with the exception of skin tumors and non melanomatous carcinoma in situ,
- Anterior resection pulmonary parenchyma, severe respiratory failure against-indicating any invasive procedure on the lung,
- Signs of presence and / or symptoms that may be due to a pre-existing cancer (eg, unexplained weight loss of more than 10% of initial body weight over the last 12 months, hemoptysis, ...)
- ECOG activity index ≥ 2,
- Acute respiratory infection that led to antibiotic therapy within 12 weeks prior to study entry,
- Renal impairment does not authorize, where appropriate, a contrast agent injection,
- Comorbidity (s) may increase the risk of death during the course of the trial.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Tobacco smoke is the most common source of exposure to carcinogens in humans. Indeed, the smoke contains about 1010 particles per ml and 4800 chemical compounds, at least 66 are carcinogenic. Tobacco smoke is the leading preventable cause of cancer in humans since it is responsible for lung cancer, upper aerodigestive tract (mouth, pharynx, larynx, esophagus), nasal cavity and sinuses, stomach, pancreas, liver, bladder, kidney, uterine cervix, and some myeloid leukemias.
This study aims to evaluate the combined effect of the scanner and the search for circulating tumor cells (CTC) on screening for tobacco-related cancers, accompanying smokers to cessation and addressing the psychological impact this approach.
Read the detailed description
Study Objectives:
The study takes two lines of research:
1 - Imaging and Research circulating tumor cells:
The main objective is to evaluate the diagnostic value of the couple scanner low intensity and speed search of circulating tumor cells (CTC-LDCT) for screening in a population at high risk of lung cancer.
The secondary objectives are:
- / comparing the added diagnostic value of dual-CTC LDCT screening that screening with LDCT used alone as it was used in the NLST study for lung cancer screening;
- / to assess the interest assess the diagnostic value of research of circulating tumor cells to identify extrapulmonary cancers associated with smoking; 3 / evaluate the psychological effects of screening (see psychological study).
2 - Psychological Study The main objective is to study the emotional and psychosocial consequences of LDCT screening in the specific context of circulating tumor cells. This is to identify 1 / specific mechanisms of fear, anxiety and mental distress, 2 / adaptation strategies that could be beneficial for other patients, 3 / specific stressors caused by the device screening and / or medical information given to patients.
The secondary objective is to adjust and improve the communication skills of health professionals in order to develop an appropriate framework to support the emotional and psychological aspects involved in the screening process when ( will be) used daily in clinical practice.
Study Design
- - Imaging and Research circulating tumor cells This is a prospective cohort study, multicenter (hospitals attached to the University Paris Descartes), open, non-randomized, single arm. Each subject enrolled in the study will undergo three screening procedures. Patients with cancer prevalent in the first exam will be offered treatment after the balance sheet. Only subjects who do not have cancer at the first examination will return to the actual screening study in search of incident cases. The same sequence of evaluation will be repeated once a year for 2 years.
- - Psychological Study To achieve the objectives, a qualitative study based on grounded theory ( "grounded theory") will be built. Grounded theory is a research methodology that studies the psychosocial processes to make them modeled theoretically. Since this method involves small samples of subjects, promotes flexibility of data collection and detailed analysis of the cases studied.
- Conditions
- Tobacco, Cancer, Screening, Psychology, Lung
- Being tested
- medical imaging, Identification of Circulating Tumor Cells, Psychological Questionnaires
- Keywords
- Circulating Tumor Cells, Lung
- Medical subject headings
- Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical imagingDevice
Low-dose CT-scanner
Identification of Circulating Tumor CellsBiological
Research of circulating tumor cells in blood
Psychological QuestionnairesProcedure or surgery
The procedure of screening test could be stressful. "False positive" results can cause anxiety and lead to additional costs, as well as increased exposure to radiation and invasive medical examination. Although this is based on some objective results, there is a high probability of adverse psychological effects in case of false positives; so there is cause for concern in the short term anxiety associated with positive results and the use of additional tests during the intervals between screening phases. There is no data related to psychological distress potentially caused by the discovery of circulating tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| Screening program | Experimental | Who consults or is hospitalized in a medical services or vascular surgery 'Paris Saint Joseph Hospital Group' (GHPSJ) or 'the European Hospital Georges Pompidou' (HEGP) for occlusive arterial disease or aneurysm the abdominal aorta. This population should accept to have a medical imaging Low-dose CT-scanner and an Identification of Circulating Tumor Cells on their blood. 30 first patients will be proposing to particpate to the psychologic sub-study by answering to a Psychological Questionnaires Receives: Device: medical imaging; Biological: Identification of Circulating Tumor Cells; Procedure: Psychological Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of the number of patients diagnosed by LDCT
number of patients diagnosed by LDCT (Low Dose CT-scanner)
Measured: Day 1, Month 6, Month 12
Assessment change of the number of patients diagnosed with CTC identification
Number of patients diagnosed with CTC (Circulating Tumor Cells) identification
Measured: Day 1, Month 6, Month 12
Secondary outcomes (1)
Assessment of the psychologic impact of screening a cancer
A psychologist-researcher attended with patient at the first consultation by the physician. The actual psychological study will be proposed as voluntary patients to participate (30 patients). It will consist of extensive interviews, lasting approximately 60 to 90 minutes, led by psychologist-researcher in principle without exceeding 3 interviews for each patient. These interviews will aim to assess the nature of the psychological impact that screening has had on you and your resources to cope
Measured: Day 1,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start23 Jan 2017
- Primary completion20 Jul 2020
- Study completion23 Dec 2023 (estimated)
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 TobaccoStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TREDANIEL Jean, PhD, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849041
- Sponsor's protocol ID
- DETECToR
- Acronym
- DETeCTOR
- Status last verified
- Mar 2023
- First submitted
- 21 Jul 2016
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yannoutsos A, Fontaine M, Galloula A, Damotte D, Chatellier G, Paterlini-Brechot P, Meyer G, Pastre J, Duchatelle V, Marini V, Schwering KL, Lazareth I, Ghaffari P, Stansal A, Sanson H, Labrousse C, Beaussier H, Nasr NB, Zins M, Salmeron S, Messas E, Lajonchere JP, Emmerich J, Priollet P, Tredaniel J. Peripheral arterial disease and systematic detection of circulating tumor cells: rationale and design of the DETECTOR prospective cohort study. BMC Cardiovasc Disord. 2019 Sep 13;19(1):212. doi: 10.1186/s12872-019-1193-1.
PubMed 31519196
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Tobacco-induced Cancers by Low-dose CT-scanner and Identification of Circulating Tumor Cells
- ClinicalTrials.gov ID
- NCT02849041
- Acronym / sponsor ID
- DETeCTOR / DETECToR
- Conditions
- Tobacco, Cancer, Screening, Psychology, Lung
- Keywords
- Circulating Tumor Cells, Lung
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 23 Dec 2023 (estimated)
- First posted
- 29 Jul 2016 (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.
Tobacco smoke is the most common source of exposure to carcinogens in humans. Indeed, the smoke contains about 1010 particles per ml and 4800 chemical compounds, at least 66 are carcinogenic. Tobacco smoke is the leading preventable cause of cancer in humans since it is responsible for lung cancer, upper aerodigestive tract (mouth, pharynx, larynx, esophagus), nasal cavity and sinuses, stomach, pancreas, liver, bladder, kidney, uterine cervix, and some myeloid leukemias.
This study aims to evaluate the combined effect of the scanner and the search for circulating tumor cells (CTC) on screening for tobacco-related cancers, accompanying smokers to cessation and addressing the psychological impact this approach.
Detailed description
Study Objectives:
The study takes two lines of research:
1 - Imaging and Research circulating tumor cells:
The main objective is to evaluate the diagnostic value of the couple scanner low intensity and speed search of circulating tumor cells (CTC-LDCT) for screening in a population at high risk of lung cancer.
The secondary objectives are:
- / comparing the added diagnostic value of dual-CTC LDCT screening that screening with LDCT used alone as it was used in the NLST study for lung cancer screening;
- / to assess the interest assess the diagnostic value of research of circulating tumor cells to identify extrapulmonary cancers associated with smoking; 3 / evaluate the psychological effects of screening (see psychological study).
2 - Psychological Study The main objective is to study the emotional and psychosocial consequences of LDCT screening in the specific context of circulating tumor cells. This is to identify 1 / specific mechanisms of fear, anxiety and mental distress, 2 / adaptation strategies that could be beneficial for other patients, 3 / specific stressors caused by the device screening and / or medical information given to patients.
The secondary objective is to adjust and improve the communication skills of health professionals in order to develop an appropriate framework to support the emotional and psychological aspects involved in the screening process when ( will be) used daily in clinical practice.
Study Design
- - Imaging and Research circulating tumor cells This is a prospective cohort study, multicenter (hospitals attached to the University Paris Descartes), open, non-randomized, single arm. Each subject enrolled in the study will undergo three screening procedures. Patients with cancer prevalent in the first exam will be offered treatment after the balance sheet. Only subjects who do not have cancer at the first examination will return to the actual screening study in search of incident cases. The same sequence of evaluation will be repeated once a year for 2 years.
- - Psychological Study To achieve the objectives, a qualitative study based on grounded theory ( "grounded theory") will be built. Grounded theory is a research methodology that studies the psychosocial processes to make them modeled theoretically. Since this method involves small samples of subjects, promotes flexibility of data collection and detailed analysis of the cases studied.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening program | Experimental | Device: medical imaging, Biological: Identification of Circulating Tumor Cells, Procedure: Psychological QuestionnairesWho consults or is hospitalized in a medical services or vascular surgery 'Paris Saint Joseph Hospital Group' (GHPSJ) or 'the European Hospital Georges Pompidou' (HEGP) for occlusive arterial disease or aneurysm the abdominal aorta. This population should accept to have a medical imaging Low-dose CT-scanner and an Identification of Circulating Tumor Cells on their blood. 30 first patients will be proposing to particpate to the psychologic sub-study by answering to a Psychological Questionnaires |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject with at least a cumulative smoking 30 pack-years,
- Active or weaned smoking since less than 15 years,
- Who consults or is hospitalized in a medical services or vascular surgery 'Paris Saint Joseph Hospital Group' (GHPSJ) or 'the European Hospital Georges Pompidou' (HEGP) for occlusive arterial disease or aneurysm the abdominal aorta,
- Accepting the repeat CT scans and blood tests, as provided for by the protocol and additional investigations which might be necessitated by the detection of abnormality (s) to previous reviews,
- Accepting, in case of continuing active smoking, engage in smoking cessation process.
Key exclusion criteria (8 listed)
- Bronchial history of cancer,
- Diagnosis and / or previous treatment of another cancer within 5 years prior to study entry, with the exception of skin tumors and non melanomatous carcinoma in situ,
- Anterior resection pulmonary parenchyma, severe respiratory failure against-indicating any invasive procedure on the lung,
- Signs of presence and / or symptoms that may be due to a pre-existing cancer (eg, unexplained weight loss of more than 10% of initial body weight over the last 12 months, hemoptysis, ...)
- ECOG activity index ≥ 2,
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 imagingLow-dose CT-scanner | Device | Screening program |
| Identification of Circulating Tumor CellsResearch of circulating tumor cells in blood | Biological | Screening program |
| Psychological QuestionnairesThe procedure of screening test could be stressful. "False positive" results can cause anxiety and lead to additional costs, as well as increased exposure to radiation and invasive medical examination. Although this is based on some objective results, there is a high probability of adverse psychological effects in case of false positives; so there is cause for concern in the short term anxiety associated with positive results and the use of additional tests during the intervals between screening phases. There is no data related to psychological distress potentially caused by the discovery of circulating tumor cells. | Procedure or surgery | Screening program |
Primary outcome
Assessment of change of the number of patients diagnosed by LDCT
Time frame: Day 1, Month 6, Month 12
number of patients diagnosed by LDCT (Low Dose CT-scanner)
Assessment change of the number of patients diagnosed with CTC identification
Time frame: Day 1, Month 6, Month 12
Number of patients diagnosed with CTC (Circulating Tumor Cells) identification
1 secondary outcome
Assessment of the psychologic impact of screening a cancer
Time frame: Day 1,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Derived from this study: PubMed 31519196Yannoutsos A, Fontaine M, Galloula A, Damotte D, Chatellier G, Paterlini-Brechot P, Meyer G, Pastre J, Duchatelle V, Marini V, Schwering KL, Lazareth I, Ghaffari P, Stansal A, Sanson H, Labrousse C, Beaussier H, Nasr NB, Zins M, Salmeron S, Messas E, Lajonchere JP, Emmerich J, Priollet P, Tredaniel J. Peripheral arterial disease and systematic detection of circulating tumor cells: rationale and design of the DETECTOR prospective cohort study. BMC Cardiovasc Disord. 2019 Sep 13;19(1):212. doi: 10.1186/s12872-019-1193-1.
- Individual participant dataSharing planned: Undecided
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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.
TREDANIEL Jean, PhD, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical imaging, Identification of Circulating Tumor Cells and Psychological Questionnaires in people with Tobacco and Cancer, run by Fondation Hôpital Saint-Joseph 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 5 inclusion and 8 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 7 Mar 2023. 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?
Assessment of change of the number of patients diagnosed by LDCT (time frame: Day 1, Month 6, Month 12). The study lists 2 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 NCT02849041, 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 7 Mar 2023.