Identification of Occupational Exposures in Acute Hematologic Malignancy

NCT03316209 | Completed

• 1 other identifier: RHELYPRO
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 7

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.

Conditions

Non Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• ability of the questionnaire to identify occupational carcinogenic exposures

  included patient will complete a questionnaire (duration: 2 hours). this questionnaire will be interpreted by an expert physician in occupational diseases

  day 1

Secondary Outcomes (4)

• Acceptability of the questionnaire by patients

  day 1

• Determination of the number of subjects recorded as suffering of an occupational disease

  day 1

• Professional sectors concerned by each nuisance

  day 1

• Activities concerned by each nuisance

  day 1

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• HIV infection
• History of organ or marrow transplant

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• ANSES: collaborator

Study Sites (7)

CHU Bordeaux

Bordeaux, France

Location

CHU Caen

Caen, France

Location

CHU H. Mondor

Créteil, 94000, France

Location

Service de pathologie professionelle

Créteil, 94000, France

Location

CHRU Lille

Lille, France

Location

Fernand Widal hospital

Paris, France

Location

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell; Multiple Myeloma

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Murielle GAIN, MD

  Centre Hospitalier intercommunal de Créteil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: October 20, 2017
• Study Start: April 27, 2017
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

FR (7)