Identification of Occupational Exposures in Acute Hematologic Malignancy

Multiple Myeloma Clinical Trial

— RHELYPRO  

Official title:

Identification of Occupational Exposures in Acute Hematologic Malignancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316209
• Other study ID #: RHELYPRO
• Status: Completed
• Start date: April 27, 2017
• Est. completion date: March 26, 2019

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: March 26, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Hematologic Neoplasms
• Leukemia, Lymphocytic, Chronic, B-Cell
• Multiple Myeloma
• Non Hodgkin Lymphoma

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	CHU Caen	Caen
France	CHU H. Mondor	Créteil
France	Service de pathologie professionelle	Créteil
France	CHRU Lille	Lille
France	Fernand Widal hospital	Paris
France	CHU Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	ANSES

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acceptability of the questionnaire by patients		day 1
Secondary	Determination of the number of subjects recorded as suffering of an occupational disease		day 1
Secondary	Professional sectors concerned by each nuisance		day 1
Secondary	Activities concerned by each nuisance		day 1