Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT02849041 |
Other study ID # |
DETECToR |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 23, 2017 |
Est. completion date |
December 23, 2023 |
Study information
Verified date |
March 2023 |
Source |
Groupe Hospitalier Paris Saint Joseph |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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.
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.