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- Study Description
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Important Links and Information
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- Instructions for requestors
- Data Use Certification (DUC) Agreement
- Talking Glossary of Genetic Terms
The overall goal of the proposed project is to identify innate host functions that contribute to cure or failure during antileishmanial drug therapy, and their related biomarkers. Results from this project enabled the identification of host-specific predictive and prognostic signatures of therapeutic responsiveness, and the bases for rational selection of host-targeted therapeutics that redirect inflammation and revert pathogenicity. Through sequential transcriptomic profiling of blood monocytes (Mo), neutrophils (Nφ), and eosinophils (Eφ) over the course of systemic treatment with meglumine antimoniate, we discovered that a heightened and sustained Type I interferon (IFN) response signature is a hallmark of treatment failure (TF) in Cutaneous Leishmaniasis (CL) patients. The transcriptomes of pre-treatment, mid-treatment and end-of-treatment samples were interrogated to identify predictive and prognostic biomarkers of TF. Results from this study instigate the evaluation of Type-I IFN responses as new immunological targets for host-directed therapies for treatment of CL, and highlight the feasibility of using transcriptional signatures as predictive biomarkers of outcome for therapeutic decision making.
- Study Design:
- Prospective Longitudinal Cohort
- Study Type:
- Full Transcriptome Sequencing
- Total number of consented subjects: 40
- Subject Sample Telemetry Report (SSTR)
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- Authorized Access
- Publicly Available Data
- Study Inclusion/Exclusion Criteria
Inclusion Criteria:
- Patients with parasitological diagnosis of cutaneous leishmaniasis
- Time of lesion evolution < 6 months
- Age between 18 to 60 years
- Hemoglobin levels >11 g/dL for women and > 12 g/dL for men
- Voluntary participation in the study and signed informed consent
- Candidates for treatment with systemic Glucantime® or miltefosine
Exclusion Criteria:
- Mucosal, diffuse or disseminate cutaneous leishmaniasis
- Use of antileishmanial drugs in the last 13 weeks including pentavalent antimonials, amphotericin B, miltefosine, pentamidine, among others
- In the case of women, positive pregnancy test or breastfeeding
- Medical history of conditions or use of medications that affect the immune system (e.g. HIV, neoplasm, diabetes mellitus, autoimmune diseases, corticosteroids, immunomodulatory or antineoplastic drugs, etc.)
- Selected Publications
- Diseases/Traits Related to Study (MeSH terms)
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- Primary Phenotype: Host-Pathogen Interactions
- Authorized Data Access Requests
- Study Attribution
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Principal Investigators
- Maria Adelaida Gomez. CIDEIM, Cali, Valle del Cauca, Colombia.
- Najib M. El-Sayed. University of Maryland, College Park, MD, USA.
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Principal Investigators