Expression of Mif Alleles in Individuals With Leishmaniasis

NCT00401349 | Completed DMC

• 2 other identifiers: 0608001742U19AI065866
• Study Type: observational
• Target: 438
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leishmaniasis

Keywords

Leishmania; Mif Alleles; Colombia; children

Eligibility Criteria

• Age: 7 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Yale University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Centro Internacional de Entrenamiento e Investigaciones Medicas, CIDEIM

Cali, Colombia

Location

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.

MeSH Terms

Conditions

Leishmaniasis

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 20, 2006
• Study Start: December 1, 2006
• Study Completion: April 1, 2010
• Last Updated: March 30, 2020

Record last verified: 2011-08

Locations

CO (1)