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Expression of Mif Alleles in Individuals With Leishmaniasis

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00401349
First received: November 16, 2006
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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.


Condition
Leishmaniasis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Immune and Inflammatory Responses in L. (Viannia) Infection Aim 2: Expression of Mif Alleles in Individuals With Recurrent Leishmaniasis, Chronic Leishmaniasis and Asymptomatic Infection

Resource links provided by NLM:


Further study details as provided by Yale University:

Biospecimen Retention:   Samples With DNA

DNA samples from bucal swabs are being retained for genetic analyses of MIF alleles and possibly other genes associated with disease (leishmaniasis) resistance/susceptibility.


Enrollment: 438
Study Start Date: December 2006
Study Completion Date: April 2010
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.

  Eligibility

Ages Eligible for Study:   7 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
Criteria

Inclusion Criteria:

Active or historical cases of recurrent cutaneous leishmaniasis

  • Age 7-70 years
  • History of parasitologically confirmed (at time of diagnosis) recurrent leishmaniasis
  • Voluntary participation in the study
  • Written and signed Informed consent/assent forms

Active or historical cases of chronic cutaneous leishmaniasis

  • Age 7-70 years
  • History of parasitologically confirmed (at time of diagnosis) chronic leishmaniasis
  • Voluntary participation in the study
  • Written and signed Informed consent/assent forms

Asymptomatic infection

  • Age 7-70 years
  • Resident of endemic area
  • No history or evidence of active or prior dermal leishmaniasis
  • Voluntary participation in the study
  • Written and signed Informed consent/assent forms

Healthy donors

  • Age 7-70 years
  • No history or evidence of exposure to transmission of leishmaniasis
  • Voluntary participation in the study
  • Written and signed Informed consent/assent forms

Exclusion Criteria:

Pregnancy

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401349

Locations
Colombia
Centro Internacional de Entrenamiento e Investigaciones Medicas, CIDEIM
Cali, Colombia
Sponsors and Collaborators
Yale University
  More Information

No publications provided

Responsible Party: Dr. Diane McMahon-Pratt, Yale University
ClinicalTrials.gov Identifier: NCT00401349     History of Changes
Other Study ID Numbers: 06-0009, U19AI065866
Study First Received: November 16, 2006
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Leishmania
Mif Alleles
Colombia
children

Additional relevant MeSH terms:
Leishmaniasis
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic

ClinicalTrials.gov processed this record on November 25, 2014