Screening of Tobacco-induced Cancers by Low-dose CT-scanner and Identification of Circulating Tumor Cells (DETeCTOR)
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|ClinicalTrials.gov Identifier: NCT02849041|
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : November 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Cancer Screening Psychology Lung||Device: medical imaging Biological: Identification of Circulating Tumor Cells Procedure: Psychological Questionnaires||Not Applicable|
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.
- - 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Screening of Tobacco-induced Cancers by Low-dose CT-scanner and Identification of Circulating Tumor Cells|
|Actual Study Start Date :||January 23, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Screening program
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
Device: medical imaging
Biological: Identification of Circulating Tumor Cells
Research of circulating tumor cells in blood
Procedure: Psychological Questionnaires
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.
- 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
- Assessment of the psychologic impact of screening a cancer [ Time Frame: Day 1, ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849041
|Contact: TREDANIEL Jean, PhD, MD||+33 1 44 12 78 firstname.lastname@example.org|
|Contact: SALMERON Sergio, MD||+33 1 44 12 78 email@example.com|
|Groupe Hospitalier Paris Saint Joseph||Recruiting|
|Paris, Ile-de-France, France, 75014|
|Contact: BEAUSSIER Helene, PhD, PharmD +33 1 44 12 70 38 firstname.lastname@example.org|
|Contact: Mohamed CHERIFI, PharmD +33 1 44 12 70 84 email@example.com|
|Principal Investigator:||TREDANIEL Jean, PhD, MD||Groupe Hospitalier Paris Saint Joseph|