Clinical trial
Screening of Tobacco-induced Cancers by Low-dose CT-scanner and Identification of Circulating Tumor Cells
Name
DETECToR
Description
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.
Trial arms
Trial start
2017-01-23
Estimated PCD
2020-07-20
Trial end
2023-12-23
Status
Active (not recruiting)
Treatment
medical imaging
Low-dose CT-scanner
Arms:
Screening program
Identification of Circulating Tumor Cells
Research of circulating tumor cells in blood
Arms:
Screening program
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.
Arms:
Screening program
Size
176
Primary endpoint
Assessment of change of the number of patients diagnosed by LDCT
Day 1, Month 6, Month 12
Assessment change of the number of patients diagnosed with CTC identification
Day 1, Month 6, Month 12
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 176, 'type': 'ACTUAL'}}
Updated at
2023-03-07
1 organization
Organization
Fondation Hôpital Saint-Joseph