Expression of Mif Alleles in Individuals With Leishmaniasis
Condition: Leishmaniasis
MeSH terms: Leishmaniasis
Study type: Observational

Summary: 
      CIDEIM, Centro Internacional de Entrenamiento e Investigaciones Medicas, is conducting a
      research study about the disease Cutaneous Leishmaniasis, which is caused by the Leishmania
      parasite and causes skin sores. Researchers hope to find out how the human body defends
      against Leishmania. A total of 472 individuals, ages 7 to 70 years, belonging to one of the
      following groups will be included in this study: recurring disease, chronic disease, disease
      with no sign or symptoms (asymptomatic), and healthy individuals. Study procedures will
      include a questionnaire and buccal swab (swabbing of the inside of the cheek with a cotton or
      wooden applicator). In addition, asymptomatic and healthy individuals will provide a blood
      sample. Study participation will be up to 1.5 hours.
    

Detailed description: 
      The purpose of this study is to define the proportion of low and high expression Mif alleles
      in individuals with recurrent or chronic Cutaneous Leishmaniasis and compare it with that of
      individuals with asymptomatic infection and healthy donors (controls), in order to determine
      if these alleles are associated with outcome of infection. This study is part 2 of a project
      that includes DMID protocols 05-0139 and 06-0010. Specific objectives are to: determine the
      proportion of low expression (5-CATT) Mif alleles in individuals with recurrent or chronic
      cutaneous leishmaniasis, healthy donors (controls), and individuals with asymptomatic
      infection; determine the proportion of high expression (6,7,8-CATT) Mif alleles in
      individuals with recurrent or chronic cutaneous leishmaniasis, healthy donors (controls), and
      individuals with asymptomatic infection; and determine the Mif Genotype repertoire and
      frequency distribution in the endemic population of study. This study will be conducted in
      472 participants who will be enrolled into one of the following 4 groups: recurrent disease,
      chronic disease, asymptomatic infection, and healthy donors (controls). Patients (males and
      females) aged between 7-70 years with chronic or recurrent cutaneous leishmaniasis (historic
      or active) diagnosed in either Cali (CIDEIM) and Tumaco (San Andrés Hospital) on the
      Colombian Pacific Coast will be invited to participate in the study. Asymptomatic and healthy
      donors (controls) will also be enrolled. Pregnant women will not be enrolled. Consent and
      samples will be obtained during a single study visit of up to 1.5 hours. No further follow-up
      visits are planned for this study. Genetic material extracted and amplified from buccal swabs
      will be used to determine the proportion of low and high expression Mif alleles of each
      group. Expression in recurrent and chronic participants will be compared to that of
      asymptomatic participants and healthy donors (controls) in order to determine if expression
      frequencies are related to the outcome of infection. Blood samples obtained from asymptomatic
      and healthy donors will undergo in vitro blastogenesis testing to confirm
      asymptomatic/healthy donor status. Study outcome measures are: frequency of low expression
      (5-CATT) Mif alleles in participants with recurrent or chronic disease, individuals with
      asymptomatic infection and healthy donors (controls); frequency of high expression
      (6,7,8-CATT) Mif alleles in participants with recurrent or chronic disease individuals with
      asymptomatic infection and healthy donors (controls); and Mif Genotype repertoire and
      frequency distribution in the endemic population in the study site.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Active or historical cases of recurrent cutaneous leishmaniasis

          2. Active or historical cases of chronic or recurrent cutaneous leishmaniasis

          3. Endemic area controls - Resident of endemic area with no history or evidence of active
             or prior dermal leishmaniasis

          4. Healthy donors (non-exposed to leishmaniasis)
      
Biospecimen description: 
      DNA samples from bucal swabs are being retained for genetic analyses of MIF alleles and
      possibly other genes associated with disease (leishmaniasis) resistance/susceptibility.
    
Keywords: Leishmania; Mif Alleles; Colombia; children