Genomic Approaches to Dissect Human Host-pathogen Interactions in the Amazonian Rainforest (PATHO-NAT)
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ClinicalTrials.gov Identifier: NCT05981378 |
Recruitment Status :
Not yet recruiting
First Posted : August 8, 2023
Last Update Posted : April 24, 2024
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Tracking Information | |||||
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First Submitted Date | July 31, 2023 | ||||
First Posted Date | August 8, 2023 | ||||
Last Update Posted Date | April 24, 2024 | ||||
Estimated Study Start Date | August 2, 2024 | ||||
Estimated Primary Completion Date | November 20, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Genomic Approaches to Dissect Human Host-pathogen Interactions in the Amazonian Rainforest | ||||
Official Title | Genomic Approaches to Dissect Human Host-pathogen Interactions in the Amazonian Rainforest | ||||
Brief Summary | This observational study, aims to characterize with a multi-omic approach, the impact of host genetics and the pathogenic environment on immune response variation in Native Amazonians in comparison with Mestizo Amazonian, a severely underrepresented population in genomic studies. Various samples will be taken from the participants, including blood, urine, saliva, etc. From the blood sample, peripheral blood mononuclear cells will be obtained and will give us information about the differences between immune response variation of Amazonian population. From the other samples we will be able to obtain additional information on the risk factors related to the difference in the immune response of the participants. |
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Detailed Description | The Amazon rainforest is characterized by adverse climatic conditions and a great diversity of pathogenic microorganisms that, consequently, would generate a selective pressure on the human immune response with a high impact on mortality. Some of the best characterized examples of human genetic adaptation have been related to infections; for example, the alleles causing sickle cell anemia, thalassemia and malaria. In addition, the introduction of infectious diseases from the "old world" during Spanish colonization in the 15th century and the urbanization of the last few centuries in the Amazon has also generated rapid adaptation that could drive variation in immune response. However, the evolutionary mechanisms that contributed to the adaptation of human defense against the aforementioned phenomena and events in this region are poorly understood. For this reason, studying these human genetic mechanisms in native populations would allow us to identify new genes that would be associated with resistance to infections, and also to explore the signs of rapid adaptation to the environment to which Amazonian populations have been exposed throughout their history. We propose to study the variation of the immune system in Amazonian populations, studying together the degree of diversity with different approaches: genomic, epi-genomic and transcriptomic of the host and viral exposome, taking into consideration sociodemographic characteristics and comorbidities, which may shape the immune response. This study will provide new insights into variants in the human genome that affect the immune response, thereby increasing our understanding of the etiology and susceptibility to immune-related diseases, mainly tropical infectious diseases. Because human genetic studies are underrepresented in Native American populations, the knowledge gained would reduce the existing inequality in health knowledge between Native and non-Native populations. |
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Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: Whole Blood, serum, plasma, saliva, feces, peripheral blood mononuclear cells,
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Sampling Method | Probability Sample | ||||
Study Population | Amazonian Peruvian Native American and Amazonian mestizo population between 2023-2024 | ||||
Condition | Host-Pathogen Interactions | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Not yet recruiting | ||||
Estimated Enrollment |
300 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | January 30, 2025 | ||||
Estimated Primary Completion Date | November 20, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
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Listed Location Countries | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT05981378 | ||||
Other Study ID Numbers | 210828 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Universidad Peruana Cayetano Heredia | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Universidad Peruana Cayetano Heredia | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Institut Pasteur | ||||
Investigators | Not Provided | ||||
PRS Account | Universidad Peruana Cayetano Heredia | ||||
Verification Date | April 2024 |