LeishmaniasisNCT00401349
Expression of Mif Alleles in Individuals With Leishmaniasis
An observational study of Leishmaniasis, run by Yale University at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Leishmaniasis
- How many people
- 438 participants
- Where
- 1 siteColombia
- Study dates
- Dec 2006to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Centro Internacional de Entrenamiento e Investigaciones Medicas, CIDEIM
Cali
About this study
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
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.
Read the 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.
- Conditions
- Leishmaniasis
- Keywords
- Leishmania, Mif Alleles, Colombia, children
- Medical subject headings
- Leishmaniasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startDec 2006
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeishmaniasisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401349
- Sponsor's protocol ID
- 0608001742
- Other IDs
- U19AI065866
- Status last verified
- Aug 2011
- First submitted
- 16 Nov 2006
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00401349
- Acronym / sponsor ID
- 0608001742
- Conditions
- Leishmaniasis
- Keywords
- Leishmania, Mif Alleles, Colombia, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Dec 2006
- Study completion
- Apr 2010 (actual)
- First posted
- 20 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
Related trials for Leishmaniasis
RecruitingObservational study
Diagnosis and Treatment of Leishmania Infections
Kinetoplastid, Skin Diseases, Parasitic
Recruiting
Feasibility of Integrating Thermotherapy for Treatment of Cutaneous Leishmaniasis in Primary Health Care Setup
Cutaneous Leishmaniasis
Not yet recruiting
Immersive Technology Headsets to Reduce Procedural Pain and Anxiety: Feasibility and Effects in Cutaneous Leishmaniasis Patients in Pakistan
Cutaneous Leishmaniasis, Pain
RecruitingObservational study
Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis
Leishmaniasis, Cutaneous, Leishmaniasis
Not yet recruitingPhase 2
Comparison of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis
Cutaneous Leishminiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leishmaniasis, run by Yale University at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.