Immunological risk factors for smokers to develop lung tumors

Study Objective

The aim of this study is to identify potential immunological risk factors of smokers to develop lung cancer. To investigate the above (potential) immunological risk factors for smokers to develop lung cancer, the study is divided in two parts, a retrospective and a prospective part.

For the retrospective study which only occurs in Luxembourg, stored serum samples from donors and patients of the Centre Hospitalier de Luxembourg (CHL) will be analyzed.

For the prospective study, donors and patients (smokers and non-smokers) will be recruited in Luxembourg and Germany. Blood samples from Luxembourgish recruits will be collected together with the study “Biomarker Discovery and validation in lung cancer”.  Ethical approval for a joint sample collection has been already given by the CNER

Blood samples will be collected by the Clinical Epidemiological Investigation Centre (CIEC) and sample-stocks will be stored at the IBBL (Integrated BioBank of Luxembourg).

Participation conditions

Participants are divided in 4 groups:

• Group 1: Patients with diagnosed lung cancer (n=200), stratified according to their smoking habits
• Group 2: Individuals with dysplasia or metaplasia identified in the approved study (n=60), stratified according to their smoking habits
• Group 3: Healthy smokers (20 years packs) i.e. without diagnosed tumours (n=200)
• Group 4: Healthy non-smokers (n=200) i.e. no smoking since > 20 years, with minimal passive smoking (minimum of household or work related exposure)

It is anticipated that most of the individuals will be males above the age of 50 years. All the participants will be at least 18 years old.

Exclusion criteria

• Missing or withdrawn informed consent except for deceased patient
• Refusal to provide required information on smoking habits
• Patients or donors for whom the blood collections represent a major stress and discomfort
• Patients or donors who report immunological disease (e.g. autoimmune disease, immunodeficiency, multiple myeloma etc.)
• Donors with other ailments that may technically complicate blood drawing
• Patients and donors with a full course of immunosuppressive therapy within the last 3 months; immunosuppressive therapy includes a full course of chemotherapy and full course of radiotherapy but not surgery
• Additional exclusion criteria may be added as necessary

For the prospective study, the CIEC Study Nurse will collect a tube of blood (10 ml in dry tube for serum collection) using standard vein puncture and the usual good clinical practice. After the first session, two follow up blood-drawing sessions are planned 1 and 2 years later.
 

CHL