Clinical trial NCT03316209: Identification of Occupational Exposures in Acute Hematologic Malignancy
Official title: Identification of Occupational Exposures in Acute Hematologic Malignancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Multiple Myeloma
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: ANSES
First posted: 2017-10-20
Enrollment: 205
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be proposed to all the patients diagnosed with NHL, MM and CLL aged between 20 and 80 years old, without HIV infection and history of bone marrow transplant. If the patients agree to participate, a clinical research technician or a physician will give them a 2-hour questionnaire on their past occupational and exposures to toxic products. This filled questionnaire will then be interpreted by a specialized doctor to evaluate the exposition to each toxic products.

Brief summary: Lymphoid hemopathies are a group of malignant haematological disorders characterized by clonal proliferation of cells of the lymphoid line. Non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and multiple myeloma (MM) are the most frequently encountered features of lymphoid hemopathies. Duriong the last 35 years the prevalence of these pathologies has increased in France but also in most industrialized countries. This increased can't be solely explained by demographic changes and improvements in diagnostic techniques. As a result, the involvement of environmental and professional factors is strongly suspected. Studies have shown that these diseases are associated with some professions or type of activity, including agricultural occupations, and other sectors such as agriculture, printing, woodworking. Some organic solvents and pesticides have been suspected of being risk factors of hematologic malignancies. Based on cohort studies and case-control studies, some of them have been identified by the International Cancer Research Center as associated with the occurrence of NHL with a sufficient or limited level of evidence. One of the difficulties encountered in the analysis of the literature has been the permanent evolution of the international classification of lymphoid hemopathies over the past 30 years. The old epidemiological studies are therefore difficult to interpret. Lymphoid hemopathies cover a range of different conditions, thus it is likely that carcinogens involved vary according to the type of hemopathy. Finally, environmental and occupational exposures to various chemicals and biological agents have evolved over time. The aim of this study is firstly to develop and validate a questionnaire to identify and quantify exposures to nuisances (substances and agents) suspected of being associated with the occurrence of NHL, MM and LLC. In a second time, this questionnaire will be used as a support for the realization of a subsequent case-control study to improve epidemiological knowledge on these diseases.

Detailed description: This study is a prospective, multicenter study on patients with a diagnosis of NHL, MM or CLL. All the patients with a diagnosis of NHL, MM or CLL in the participant centers will be purposed to participate. Each patient included will have an interview with a clinical study technician or doctor of occupational medicine. A specific detailed questionnaire has been created for the study. It focuses on specialized professional careers to spread occupational exposures to nuisances (substances and agents) suspected of being associated with NHL, MM or LLC risk. Each questionnaire will be evaluated by a physician expert in occupational disease, to conclude on the parameters exposure to the various suspected carcinogens. The study will cover 300 patients.

Eligibility criteria: Inclusion Criteria:

* Incident cases of NHL, MM and CLL diagnosed in hospital hematology departments participating in the study.
* Age between 20 and 80 years

Exclusion Criteria:

* HIV infection
* History of organ or marrow transplant

Primary outcomes:
measure: ability of the questionnaire to identify occupational carcinogenic exposures
timeFrame: day 1
Secondary outcomes:
measure: Acceptability of the questionnaire by patients
timeFrame: day 1
measure: Determination of the number of subjects recorded as suffering of an occupational disease
timeFrame: day 1
measure: Professional sectors concerned by each nuisance
timeFrame: day 1
measure: Activities concerned by each nuisance
timeFrame: day 1
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Caen
country: France
facility: CHU Caen
city: Créteil
country: France
facility: CHU H. Mondor
city: Créteil
country: France
facility: Service de pathologie professionelle
city: Lille
country: France
facility: CHRU Lille
city: Paris
country: France
facility: Fernand Widal hospital
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: Centre Hospitalier intercommunal de Créteil
name: Murielle GAIN, MD
role: PRINCIPAL_INVESTIGATOR
References: