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

NCT02849041 | Unknown DMC

• 1 other identifier: DETECToR
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco; Cancer; Screening; Psychology; Lung

Keywords

Circulating Tumor Cells; Lung

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Assessment of the psychologic impact of screening a cancer

  Day 1,

Study Arms (1)

Screening program

EXPERIMENTAL

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. This population should accept to have a medical imaging Low-dose CT-scanner and an Identification of Circulating Tumor Cells on their blood. 30 first patients will be proposing to particpate to the psychologic sub-study by answering to a Psychological Questionnaires

Device: medical imaging; Biological: Identification of Circulating Tumor Cells; Procedure: Psychological Questionnaires

Interventions

medical imaging DEVICE

Low-dose CT-scanner

Screening program

Identification of Circulating Tumor Cells BIOLOGICAL

Research of circulating tumor cells in blood

Screening program

Psychological Questionnaires PROCEDURE

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.

Screening program

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

• 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.

  PMID: 31519196 DERIVED

MeSH Terms

Conditions

Neoplasms; Neoplastic Cells, Circulating

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• TREDANIEL Jean, PhD, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 29, 2016
• Study Start: January 23, 2017
• Primary Completion: July 20, 2020
• Study Completion: December 23, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

FR (1)