Screening of Tobacco-induced Cancers by Low-dose CT-scanner and Identification of Circulating Tumor Cells — DETeCTOR  

Cancer Clinical Trial

Official title: Screening of Tobacco-induced Cancers by Low-dose CT-scanner and Identification of Circulating Tumor Cells

Status Active, not recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cancer
• Lung
• Neoplastic Cells, Circulating
• Psychology
• Screening
• Tobacco

• NCT number: NCT02849041
• Study type: Interventional
• Source: Groupe Hospitalier Paris Saint Joseph
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 23, 2017
• Completion date: December 23, 2023