UnknownNot Applicable

Epidemiology of Leprosy in French Guiana

French Guiana368 participantsStarted 2020-01-07

Plain-language summary

The main objective of the present study is the genotyping of M. leprae strains found in leprosy patients in French Guiana. The secondary objectives are to investigate the presence of M. lepromatosis in these patients, the molecular research of M. leprae resistance to anti-leprosy antibiotics, the study of risk factors for leprosy in humans in Guyana and in particular direct or indirect contact with armadillos, as well as the determination of phylogenetic links between the M. leprae strains found in French Guiana, and with the regional and world reference strains Epidemiology of leprosy in French Guiana.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: FOR TRANSVERSAL STUDY: * any patient, regardless of age, consulting a practitioner at the Cayenne Hospital with a clinical suspicion of leprosy * Diagnosis of leprosy, confirmed histologically or bacteriologically, made in Guyana between 2006 and 2022 * Skin biopsy (or dermal smear or nasal swab) available in the anatomopathology department of the Andrée Rosemon Hospital and analysable (correct state of preservation and sufficient quantity of tissue) FOR CASE-CONTROL STUDY - CASES: * any patient, regardless of age, consulting a practitioner at the Cayenne Hospital with a clinical suspicion of leprosy * Diagnosis of leprosy, confirmed histologically or bacteriologically, made in Guyana between 2006 and 2022 FOR CASE-CONTROL STUDY - CONTROL: Any patient, of any age, consulting for a dermatological pathology not clinically suspicious of leprosy during a dermatological consultation by a practitioner of the Cayenne Hospital Exclusion Criteria: FOR TRANSVERSAL STUDY: * Opposition to participation * Diagnosis of leprosy invalidated after inclusion FOR CASE-CONTROL STUDY - CASES: * Opposition to participation * Inability to answer to the questionnaire * Diagnosis of leprosy invalidated after inclusion FOR CASE-CONTROL STUDY - CONTROL: * Opposition to participation * Inability to answer to the questionnaire

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Genotype of M. Leprae srtrains

Timeframe: 1 day

Trial details

NCT IDNCT05031091

SponsorCentre Hospitalier de Cayenne

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Hansen's Disease trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.