Lymphoma Diffuse Large B-cellProLyPhyNCT02898870
Occupational Exposure to Pesticides in the Prognosis of Lymphomas
An observational study of Lymphoma Diffuse Large B-cell, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The link between the products of synthetic chemistry and cancer is at the heart of much research. Recent work has identified the use of plant protection agents by farmers as a risk factor for developing non-Hodgkin lymphoma, including diffuse large B cell lymphoma (DLBCL) is the most common histology. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphoma Diffuse Large B-cell
- How many people
- 244 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Apr 2018
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults treated for diffuse large B-cell lymphoma:
Who may be able to join
- Adults treated for diffuse large B-cell lymphoma:
- Diagnosed between 2010 and 2015
- Having received immuno-chemotherapy R-CHOP
- Supported in the health facilities of the Languedoc-Rousillon
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Role of Occupational Exposure to Pesticides in the Prognosis of Lymphomas Diffuse Large B Cell in
The link between the products of synthetic chemistry and cancer is at the heart of much research. Recent work has identified the use of plant protection agents by farmers as a risk factor for developing non-Hodgkin lymphoma, including diffuse large B cell lymphoma (DLBCL) is the most common histology. Different biological models were used to understand the role of pesticides in lymphomagenesis. To summarize, most pesticides act at the cellular and molecular level, on different signaling pathways. After metabolized by cytochrome P450, these compounds generally become pro-oxidants. The increase in reactive oxygen species rate (SAR) causes the activation of signaling pathways involved in cell proliferation and survival. But deregulation of oxidative status does not in itself justify the specificity of the impact of pesticides on specific pathologies. Several agents have a genotoxic effect, others induce the activation of signaling pathways by binding to transcription factors and others have immunomodulating properties.
Read the detailed description
The link between the products of synthetic chemistry and cancer is at the heart of much research. Recent work has identified the use of plant protection agents by farmers as a risk factor for developing non-Hodgkin lymphoma, including diffuse large B cell lymphoma (DLBCL) is the most common histology. Different biological models were used to understand the role of pesticides in lymphomagenesis. To summarize, most pesticides act at the cellular and molecular level, on different signaling pathways. After metabolized by cytochrome P450, these compounds generally become pro-oxidants. The increase in reactive oxygen species rate (SAR) causes the activation of signaling pathways involved in cell proliferation and survival. But deregulation of oxidative status does not in itself justify the specificity of the impact of pesticides on specific pathologies. Several agents have a genotoxic effect, others induce the activation of signaling pathways by binding to transcription factors and others have immunomodulating properties.
Among these four mechanisms by which pesticides are involved in lymphomagenesis, two are also associated with resistance to chemotherapy. Thus, genotoxic agents leads the implementation process of DNA repair, used to repair genotoxic lesions induced by chemotherapeutic agents and evade apoptosis. On the other hand, to survive a high level of ROS, the tumor cell raises the level of antioxidant defenses, maintaining redox homeostasis and preventing oxidative stress. However, a high production of antioxidants constitutes a barrier to the effectiveness of anti-tumor agents which are effective in the generation of oxidative stress.
- Conditions
- Lymphoma Diffuse Large B-cell
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What is being measured
The primary outcome is the main question the study is designed to answer.
pesticide exposure
The exposure measurement will be carried out using a self-administered questionnaire sent to patients on their professional activities. If farming a second questionnaire will further characterize the exposure to pesticides
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionOct 2017
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma Diffuse Large B-cellStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain LAMURE, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898870
- Sponsor's protocol ID
- 9668
- Acronym
- ProLyPhy
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Occupational Exposure to Pesticides in the Prognosis of Lymphomas Diffuse Large B Cell in
- ClinicalTrials.gov ID
- NCT02898870
- Acronym / sponsor ID
- ProLyPhy / 9668
- Conditions
- Lymphoma Diffuse Large B-cell
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Apr 2018 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- 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.
The link between the products of synthetic chemistry and cancer is at the heart of much research. Recent work has identified the use of plant protection agents by farmers as a risk factor for developing non-Hodgkin lymphoma, including diffuse large B cell lymphoma (DLBCL) is the most common histology. Different biological models were used to understand the role of pesticides in lymphomagenesis. To summarize, most pesticides act at the cellular and molecular level, on different signaling pathways. After metabolized by cytochrome P450, these compounds generally become pro-oxidants. The increase in reactive oxygen species rate (SAR) causes the activation of signaling pathways involved in cell proliferation and survival. But deregulation of oxidative status does not in itself justify the specificity of the impact of pesticides on specific pathologies. Several agents have a genotoxic effect, others induce the activation of signaling pathways by binding to transcription factors and others have immunomodulating properties.
Detailed description
The link between the products of synthetic chemistry and cancer is at the heart of much research. Recent work has identified the use of plant protection agents by farmers as a risk factor for developing non-Hodgkin lymphoma, including diffuse large B cell lymphoma (DLBCL) is the most common histology. Different biological models were used to understand the role of pesticides in lymphomagenesis. To summarize, most pesticides act at the cellular and molecular level, on different signaling pathways. After metabolized by cytochrome P450, these compounds generally become pro-oxidants. The increase in reactive oxygen species rate (SAR) causes the activation of signaling pathways involved in cell proliferation and survival. But deregulation of oxidative status does not in itself justify the specificity of the impact of pesticides on specific pathologies. Several agents have a genotoxic effect, others induce the activation of signaling pathways by binding to transcription factors and others have immunomodulating properties.
Among these four mechanisms by which pesticides are involved in lymphomagenesis, two are also associated with resistance to chemotherapy. Thus, genotoxic agents leads the implementation process of DNA repair, used to repair genotoxic lesions induced by chemotherapeutic agents and evade apoptosis. On the other hand, to survive a high level of ROS, the tumor cell raises the level of antioxidant defenses, maintaining redox homeostasis and preventing oxidative stress. However, a high production of antioxidants constitutes a barrier to the effectiveness of anti-tumor agents which are effective in the generation of oxidative stress.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults treated for diffuse large B-cell lymphoma:
Key inclusion criteria (4 listed)
- Diagnosed between 2010 and 2015
- Having received immuno-chemotherapy R-CHOP
- Supported in the health facilities of the Languedoc-Rousillon
Key exclusion criteria (1 listed)
- NA
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
pesticide exposure
Time frame: 1 day
The exposure measurement will be carried out using a self-administered questionnaire sent to patients on their professional activities. If farming a second questionnaire will further characterize the exposure to pesticides
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Lymphoma Diffuse Large B-cell
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
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.
Sylvain LAMURE principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma Diffuse Large B-cell, run by University Hospital, Montpellier at 1 site 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early. Results are not available in the source record.
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?
pesticide exposure (time frame: 1 day). 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 10 Oct 2017.