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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:

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Study Design


Intervention

Device:
medical imaging
Low-dose CT-scanner
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.

Locations

Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of change of the number of patients diagnosed by LDCT number of patients diagnosed by LDCT (Low Dose CT-scanner) Day 1, Month 6, Month 12
Primary Assessment change of the number of patients diagnosed with CTC identification Number of patients diagnosed with CTC (Circulating Tumor Cells) identification Day 1, Month 6, Month 12
Secondary 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 Day 1,
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