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

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ClinicalTrials.gov Identifier: NCT02849041
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

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.


Condition or disease Intervention/treatment Phase
Tobacco Cancer Screening Psychology Lung Device: medical imaging Biological: Identification of Circulating Tumor Cells Procedure: Psychological Questionnaires Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening of Tobacco-induced Cancers by Low-dose CT-scanner and Identification of Circulating Tumor Cells
Actual Study Start Date : January 23, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Screening program
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
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.




Primary Outcome Measures :
  1. Assessment of change of the number of patients diagnosed by LDCT [ Time Frame: Day 1, Month 6, Month 12 ]
    number of patients diagnosed by LDCT (Low Dose CT-scanner)

  2. Assessment change of the number of patients diagnosed with CTC identification [ Time Frame: Day 1, Month 6, Month 12 ]
    Number of patients diagnosed with CTC (Circulating Tumor Cells) identification


Secondary Outcome Measures :
  1. Assessment of the psychologic impact of screening a cancer [ Time Frame: Day 1, ]
    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



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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849041


Contacts
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Contact: TREDANIEL Jean, PhD, MD +33 1 44 12 78 05 jtredaniel@hpsj.fr
Contact: SALMERON Sergio, MD +33 1 44 12 78 05 ssalmeron@hpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint Joseph Recruiting
Paris, Ile-de-France, France, 75014
Contact: BEAUSSIER Helene, PhD, PharmD    +33 1 44 12 70 38    hbeaussier@hpsj.fr   
Contact: Mohamed CHERIFI, PharmD    +33 1 44 12 70 84    mcherifi@hpsj.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: TREDANIEL Jean, PhD, MD Groupe Hospitalier Paris Saint Joseph

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT02849041     History of Changes
Other Study ID Numbers: DETECToR
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
Circulating Tumor Cells
Lung
Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes