Non Hodgkin LymphomaRHELYPRONCT03316209
Identification of Occupational Exposures in Acute Hematologic Malignancy
An observational study of Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Centre Hospitalier Intercommunal Creteil at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Multiple Myeloma
- How many people
- 205 participants
- Where
- 7 sitesFrance
- Study dates
- 27 Apr 2017to 26 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Incident cases of NHL, MM and CLL diagnosed in hospital hematology departments participating in the study.
- Age between 20 and 80 years
Who cannot join
- HIV infection
- History of organ or marrow transplant
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Bordeaux
Bordeaux
CHU Caen
Caen
CHU H. Mondor
Créteil, 94000
Service de pathologie professionelle
Créteil, 94000
CHRU Lille
Lille
Fernand Widal hospital
Paris
CHU Toulouse
Toulouse
About this study
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.
Read the 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.
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Secondary outcomes (4)
Acceptability of the questionnaire by patients
Measured: day 1
Determination of the number of subjects recorded as suffering of an occupational disease
Measured: day 1
Professional sectors concerned by each nuisance
Measured: day 1
Activities concerned by each nuisance
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start27 Apr 2017
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- ANSES
- Responsible party
- Sponsor
- Investigators
- Murielle GAIN, MD, Principal investigator, Centre Hospitalier intercommunal de Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316209
- Sponsor's protocol ID
- RHELYPRO
- Acronym
- RHELYPRO
- Status last verified
- Feb 2023
- First submitted
- 1 Aug 2017
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Occupational Exposures in Acute Hematologic Malignancy
- ClinicalTrials.gov ID
- NCT03316209
- Acronym / sponsor ID
- RHELYPRO / RHELYPRO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- ANSES
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Incident cases of NHL, MM and CLL diagnosed in hospital hematology departments participating in the study.
- Age between 20 and 80 years
Key exclusion criteria (2 listed)
- HIV infection
- History of organ or marrow transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ability of the questionnaire to identify occupational carcinogenic exposures
Time frame: day 1
included patient will complete a questionnaire (duration: 2 hours). this questionnaire will be interpreted by an expert physician in occupational diseases
4 secondary outcomes
Acceptability of the questionnaire by patients
Time frame: day 1
Determination of the number of subjects recorded as suffering of an occupational disease
Time frame: day 1
Professional sectors concerned by each nuisance
Time frame: day 1
Activities concerned by each nuisance
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murielle GAIN, MD principal investigator
Centre Hospitalier intercommunal de Créteil
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Centre Hospitalier Intercommunal Creteil at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ability of the questionnaire to identify occupational carcinogenic exposures (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.