NCT04260490

Brief Summary

Multiple myeloma (MM) is a malignancy of plasma cells engaging in monoclonal immunoglobulin production. A strong presumption was established between exposure to pesticides and the risk of MM. The French West Indies departments of Guadeloupe and Martinique are characterized by a wide use of pesticides related to bananas plantation, particularly chlordecone which has been classified by IARC as possibly carcinogenic and has recognized hormonal properties (endocrine disruptor). The objective of this study is to measure the association between exposure to pesticide and other environmental factors in the occurrence of MM in Guadeloupe and Martinique and to estimate the proportion of cases of MM attributable to pesticide exposure. Genetic susceptibility markers and their links to environmental factors will be subsequently studies from blood samples collection.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

February 5, 2020

Last Update Submit

February 6, 2020

Conditions

Multiple Myeloma

Keywords

Multiple myelomapesticidechlordeconeGuadeloupeMartinique

Outcome Measures

Primary Outcomes (1)

  • Measure of association between exposure to chlordecone and risk of multiple myeloma.

    The exposure measurement will be done using several complementary methods combining: * Serum dosages of chlordecone + Persistent Organic Pollutant * Evaluation from questionnaires * Use of job-exposure matrices (benzene and other solvents), made available by the Occupational Health Department (DST) of the Institute for Health Monitoring (InVS) * Use of crop-exposure matrices : the banana crop matrix developed for the Antilles by the DST of InVS in collaboration with the Interregional Epidemiology Unit (CIRE) Antilles Guyane and will be used

    Pesticide samples will be sent to the Reference Laboratory of Animal Ecology and Ecotoxicology in Liège once or twice a year. For a given patient, the time frame (questionnaire + and blood analyses) will be 12 months after inclusion.

Secondary Outcomes (1)

  • proportion of MM cases attributable to pesticide exposure

    36 months after first inclusion

Study Arms (2)

Cases

Cases will be interviewed using a standardized questionnaire. Blood samples will be taken for standard and specific analyses. Samples for chlordecone and other Persistent organic Polluants (POPs) tests will be collected. Blood samples will be collected for the biobank of Guadeloupe for further studies on genetic susceptibility markers and their links with pesticide exposure.

Controls

Controls selected after stratification on department of residence, sex and age of the cases and who give a written informed consent to participate. Controls will be interviewed using a standardized questionnaire. Blood samples will be taken for standard and specific analyses in both cases and controls. Samples for chlordecone and other Persistent organic Polluants (POPs) tests will be collected. Blood samples will be collected for the biobank of Guadeloupe for further studies on genetic susceptibility markers and their links with pesticide exposure.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A case-control study in the general population with etiological aim, paired multicentric will be carried out. This choice is justified given the low frequency of the pathology studied in the two islands. Cancer registries of Guadeloupe and Martinique exhaustively collect cases of multiple myeloma (MM) according to cancer registration rules established at European and international level. They have data to identify the usual places of care and diagnosis of MM in their respective territory and work in close collaboration with clinical services in charge of patients.

You may qualify if:

  • Cases :
  • patients above 18 years old
  • with a place of residence in Guadeloupe or Martinique
  • who ave a written informed consent.
  • Controls :
  • individuals selected after stratification on department of residence, sex and age of the cases
  • who gave a written informed consent to participate.

You may not qualify if:

  • Refusal to participate
  • subject not affiliated to a social welfare or under guardianship
  • Pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Center of Guadeloupe

Pointe-à-Pitre, 97159, Guadeloupe

RECRUITING

University Hospital Center of Martinique

Fort-de-France, 97261, Martinique

NOT YET RECRUITING

Related Publications (2)

  • Flowers CR, Glover R, Lonial S, Brawley OW. Racial differences in the incidence and outcomes for patients with hematological malignancies. Curr Probl Cancer. 2007 May-Jun;31(3):182-201. doi: 10.1016/j.currproblcancer.2007.01.005. No abstract available.

    PMID: 17543947BACKGROUND

  • Multigner L, Ndong JR, Giusti A, Romana M, Delacroix-Maillard H, Cordier S, Jegou B, Thome JP, Blanchet P. Chlordecone exposure and risk of prostate cancer. J Clin Oncol. 2010 Jul 20;28(21):3457-62. doi: 10.1200/JCO.2009.27.2153. Epub 2010 Jun 21.

    PMID: 20566993BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma collection and DNA collection

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jacqueline Deloumeaux, MD

    CHU de la Guadeloupe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie VS SOTER, MD

CONTACT

+590590934686valerie.soter@chu-guadeloupe.fr

Mélanie MP PETAPERMAL

CONTACT

melanie.petapermal@chu-guadeloupe.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 7, 2020

Study Start

November 19, 2019

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

February 7, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

GU(1)MA(1)