Circulating Tumor Cells in Lung Cancer Screening

Not Applicable

Completed

• Conditions: Lung Neoplasms; Pulmonary Disease, Chronic Obstructive
• Interventions: Biological: Isolation of circulating tumor cells (CTC) from veinous blood

• Registration Number: NCT02500693
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-16
• Study Start: 2015-10-30
• Status Verified: 2018-01
• Primary Completion: 2020-10-13
• Study Completion: 2020-10-13
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 683

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].

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening	Isolation of circulating tumor cells (CTC) from veinous blood	-

Primary Outcome Measures

Name	Time	Method
Rate of detection of circulating tumor cells in patients who will have a LC detected during the study	3 years

Secondary Outcome Measures

Name	Time	Method
Rate of detection of CTC in the whole study population	once a year for 3 years
Circulating tumor cells	once a year for 3 years	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	once a year for 3 years

Trial Locations

Locations (20)

Hôpital TENON; 🇫🇷 Paris, France

CHU de Reims; 🇫🇷 Reims, France

CHU de Rouen; 🇫🇷 Rouen, France

CHU de Saint Etienne; 🇫🇷 Saint Etienne, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHRU de Lille; 🇫🇷 Lille, France

CHU d'Amiens; 🇫🇷 Amiens, France

CHU de Dijon; 🇫🇷 Dijon, France

Hôpital Nord; 🇫🇷 Marseille, France

CHU de Nancy; 🇫🇷 Nancy, France

CHU de Montpellier; 🇫🇷 Montpellier, France

Hôpital Bichat; 🇫🇷 Paris, France

CHU de Rennes; 🇫🇷 Rennes, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Hôpital Cochin; 🇫🇷 Paris, France

CH de Roubaix; 🇫🇷 Roubaix, France

CHU de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Tours; 🇫🇷 Tours, France

CHU de Toulouse; 🇫🇷 Toulouse, France