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Circulating Tumor Cells in Lung Cancer Screening (AIR)

Primary Purpose

Lung Neoplasms, Pulmonary Disease, Chronic Obstructive

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Isolation of circulating tumor cells (CTC) from veinous blood
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Neoplasms focused on measuring Lung Cancer, Screening, COPD

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 55 years or more
  • 30 or more pack-years of cigarette smoking history
  • Former smokers: quit smoking within the previous 15 years
  • Signed informed consent form
  • Presence of COPD
  • Affiliation to the French social security system

Exclusion Criteria:

  • Chest CT examination in the 12 months prior to eligibility assessment(1)
  • Treatment for, or evidence of, any cancer other than skin basocellular carcinoma in the 5 years prior to eligibility assessment
  • Pneumonia or acute respiratory infection treated with antibiotics in the 12 weeks prior to eligibility assessment
  • Unexplained weight loss of more than 15 10%pounds in the 12 months prior to eligibility assessment
  • Recent hemoptysis
  • History of lung volume reduction with coils, glue or valves°
  • Metallic implants or devices in the chest or back, such as pacemakers or Harrington fixation rods
  • Participation in another cancer screening trial
  • Participation in a cancer prevention study, other than a smoking cessation study
  • Vulnerable persons: adults under guardianship, adults under trusteeship or persons deprived of their liberty, patients under 18 years old

  • Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk

    1. Many COPD patients will have had a previous chest CT examination. This has become common in medical practice, especially in patients with chronic lung diseases such as COPD patients. Including such patients would introduce huge bias in the study by artificially focusing on rapidly growing cancers. Redoing a CT in a screening intend in a patient who recently underwent this investigation would also unnecessarily enhance irradiation in these patients. It should be note that in the NLST trial "previous chest CT (≤ 18 months)" was a key exclusion criterion [NLST Radiology 2011].

Sites / Locations

  • CHU d'Amiens
  • CHU de Dijon
  • CHU de Grenoble
  • CHRU de Lille
  • Hospices Civils de Lyon
  • Hôpital Nord
  • CHU de Montpellier
  • CHU de Nancy
  • Hôpital Bichat
  • Hôpital Cochin
  • Hôpital Européen Georges Pompidou
  • Hôpital TENON
  • CHU de Reims
  • CHU de Rennes
  • CH de Roubaix
  • CHU de Rouen
  • CHU de Saint Etienne
  • CHU de Strasbourg
  • CHU de Toulouse
  • CHU de Tours

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening

Arm Description

Outcomes

Primary Outcome Measures

Rate of detection of circulating tumor cells in patients who will have a LC detected during the study

Secondary Outcome Measures

Rate of detection of CTC in the whole study population
Circulating tumor cells
Predictive value of CTC detection for the diagnosis of LC in patients identified as having a pulmonary nodule.
Time span between detection of CTC and detection of lung cancer with LDCT and vice versa

Full Information

First Posted
July 15, 2015
Last Updated
January 8, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02500693
Brief Title
Circulating Tumor Cells in Lung Cancer Screening
Acronym
AIR
Official Title
Circulating Tumor Cells and Early Diagnosis of Lung Cancer in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2015 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial is intended to evaluate the value of circulating tumor cells (CTC), in combination with unenhanced (without injection of contrast media) low dose (to limit the effective radiation dose below 1,5 mSv) chest computed tomography (LDCT) in the screening of Lung cancer (LC). LDCT screening was shown to reduce LC mortality in smokers and ex-smokers, older than 55 years, with a history of more than 30 pack-years. LDCT however shows a close to 30% rate of false positive that require repeat follow-up and also invasive investigations, but also false negatives with metastatic LC being discovered between screening rounds. Migration of circulating tumor cells (CTC) is an early event of carcinogenesis and characterizes aggressive cancers. We recently showed that CTC can be detected with the ISET technique in a population at high risk for LC, i.e. COPD patients before LC was detectable on LDCT. The study will focus on patients at very high risk for lung cancer i.e. smokers and ex-smokers suffering Chronic Obstructive Pulmonary Disease (COPD). The study will enroll 600 participants who will undergo three rounds of screening at one year intervals, each round combining search for CTC on a blood sample and LDCT. Each participant will be followed for at least one year after the last screening round

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Pulmonary Disease, Chronic Obstructive
Keywords
Lung Cancer, Screening, COPD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Isolation of circulating tumor cells (CTC) from veinous blood
Intervention Description
Thirty ml of peripheral blood will be collected in buffered EDTA, maintained at 4°C, and processed within 1 hour for filtration. After blood filtration, the membrane will be gently washed with PBS, disassembled from the filtration module, and allowed to air-dry. The determination of CTC number present on filters will be carried out by combining four color immunofluorescent (anti-pancytokeratins/anti-vimentin/DAPI/anti-CD45) staining and cytomorphological examination after Diff-quick and Mayer Hemalun staining in three spots per patient sample. Imaging of immunofluorescent and cytological staining will be performed at x20 magnification using the automated Ariol system. CTCs are identified by relocating images of immunofluorescent and cytological staining.
Primary Outcome Measure Information:
Title
Rate of detection of circulating tumor cells in patients who will have a LC detected during the study
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Rate of detection of CTC in the whole study population
Time Frame
once a year for 3 years
Title
Circulating tumor cells
Description
Predictive value of CTC detection for the diagnosis of LC in patients identified as having a pulmonary nodule.
Time Frame
once a year for 3 years
Title
Time span between detection of CTC and detection of lung cancer with LDCT and vice versa
Time Frame
once a year for 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 55 years or more 30 or more pack-years of cigarette smoking history Former smokers: quit smoking within the previous 15 years Signed informed consent form Presence of COPD Affiliation to the French social security system Exclusion Criteria: Chest CT examination in the 12 months prior to eligibility assessment(1) Treatment for, or evidence of, any cancer other than skin basocellular carcinoma in the 5 years prior to eligibility assessment Pneumonia or acute respiratory infection treated with antibiotics in the 12 weeks prior to eligibility assessment Unexplained weight loss of more than 15 10%pounds in the 12 months prior to eligibility assessment Recent hemoptysis History of lung volume reduction with coils, glue or valves° Metallic implants or devices in the chest or back, such as pacemakers or Harrington fixation rods Participation in another cancer screening trial Participation in a cancer prevention study, other than a smoking cessation study Vulnerable persons: adults under guardianship, adults under trusteeship or persons deprived of their liberty, patients under 18 years old Medical and/or psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk Many COPD patients will have had a previous chest CT examination. This has become common in medical practice, especially in patients with chronic lung diseases such as COPD patients. Including such patients would introduce huge bias in the study by artificially focusing on rapidly growing cancers. Redoing a CT in a screening intend in a patient who recently underwent this investigation would also unnecessarily enhance irradiation in these patients. It should be note that in the NLST trial "previous chest CT (≤ 18 months)" was a key exclusion criterion [NLST Radiology 2011].
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles-Hugo MARQUETTE, Pr
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Amiens
City
Amiens
Country
France
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Facility Name
CHRU de Lille
City
Lille
Country
France
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Facility Name
Hôpital Nord
City
Marseille
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Facility Name
CHU de Nancy
City
Nancy
Country
France
Facility Name
Hôpital Bichat
City
Paris
Country
France
Facility Name
Hôpital Cochin
City
Paris
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
Country
France
Facility Name
Hôpital TENON
City
Paris
Country
France
Facility Name
CHU de Reims
City
Reims
Country
France
Facility Name
CHU de Rennes
City
Rennes
Country
France
Facility Name
CH de Roubaix
City
Roubaix
Country
France
Facility Name
CHU de Rouen
City
Rouen
Country
France
Facility Name
CHU de Saint Etienne
City
Saint Etienne
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Facility Name
CHU de Tours
City
Tours
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25360587
Citation
Ilie M, Hofman V, Long-Mira E, Selva E, Vignaud JM, Padovani B, Mouroux J, Marquette CH, Hofman P. "Sentinel" circulating tumor cells allow early diagnosis of lung cancer in patients with chronic obstructive pulmonary disease. PLoS One. 2014 Oct 31;9(10):e111597. doi: 10.1371/journal.pone.0111597. eCollection 2014.
Results Reference
background
PubMed Identifier
32649919
Citation
Marquette CH, Boutros J, Benzaquen J, Ferreira M, Pastre J, Pison C, Padovani B, Bettayeb F, Fallet V, Guibert N, Basille D, Ilie M, Hofman V, Hofman P; AIR project Study Group. Circulating tumour cells as a potential biomarker for lung cancer screening: a prospective cohort study. Lancet Respir Med. 2020 Jul;8(7):709-716. doi: 10.1016/S2213-2600(20)30081-3. Erratum In: Lancet Respir Med. 2020 Dec;8(12):e94.
Results Reference
derived
PubMed Identifier
29282271
Citation
Leroy S, Benzaquen J, Mazzetta A, Marchand-Adam S, Padovani B, Israel-Biet D, Pison C, Chanez P, Cadranel J, Mazieres J, Jounieaux V, Cohen C, Hofman V, Ilie M, Hofman P, Marquette CH; AIR Project Study Group. Circulating tumour cells as a potential screening tool for lung cancer (the AIR study): protocol of a prospective multicentre cohort study in France. BMJ Open. 2017 Dec 26;7(12):e018884. doi: 10.1136/bmjopen-2017-018884.
Results Reference
derived

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Circulating Tumor Cells in Lung Cancer Screening

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