Clinical trial NCT02849041: Screening of Tobacco-induced Cancers by Low-dose CT-scanner and Identification of Circulating Tumor Cells
Official title: Screening of Tobacco-induced Cancers by Low-dose CT-scanner and Identification of Circulating Tumor Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco
Cancer
Screening
Psychology
Lung
Keywords: Circulating Tumor Cells
Lung
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 176
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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. 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:

1. / 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;
2. / 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

1. - 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.
2. - 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of change of the number of patients diagnosed by LDCT
timeFrame: Day 1, Month 6, Month 12
measure: Assessment change of the number of patients diagnosed with CTC identification
timeFrame: Day 1, Month 6, Month 12
Secondary outcomes:
measure: Assessment of the psychologic impact of screening a cancer
timeFrame: Day 1,
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: TREDANIEL Jean, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.