Cardiovascular Diseases Clinical Trial
Official title:
AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens Involved in Diseases and Healthy Populations)
Verified date | June 2023 |
Source | Audubon Bioscience |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Study purpose: to explore the entire spectrum of proteomic and genomic changes (amongst others) involved in diseases and in healthy/control populations. The Study is designed to discover biomarkers, develop and validate diagnostic assays, instruments and therapeutics as well as other medical research. Specifically, researchers may analyze proteins, RNA, DNA copy number changes, including large and small (1,000-100,000 kb) scale rearrangements, transcription profiles, epigenetic modifications, sequence variation, and sequence in both diseased tissue and case-matched germline DNA from Subjects.
Status | Enrolling by invitation |
Enrollment | 10000 |
Est. completion date | June 10, 2043 |
Est. primary completion date | May 10, 2043 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Subject shall be at least 18 years of age, or higher if required by Applicable Law. 2. Subject's Clinical Data shall be relevant to the Study in which he/she is participating. 3. Subject shall understand and voluntarily sign the ICF prior to the Study participation. If the Subject is illiterate, the witness must sign the ICF (see 5.6. for details). If the Subject is incapable of consenting himself/herself, the legally authorized representative must sign the ICF (see 5.6. for details). 4. Subject shall meet any other additional inclusion criteria specified in Appendices to this Protocol, or in additional written instructions of the Sponsor. 5. Subject shall be able to donate the requested Specimen(s) without compromising his/her current health status. Exclusion Criteria: 1. Younger than 18 years of age, or higher if required by Applicable Law. 2. The individual is incapable of understanding the items listed in the ICF and the consent process unless consented by the legally authorized representative. 3. Prisoner |
Country | Name | City | State |
---|---|---|---|
United States | AUD | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Audubon Bioscience |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Enrollment and collection totals for a diverse population of subjects/conditions involved in diseases and in healthy/control populations. | We will total the number of subjects and characterize the totals by disease state, gender, ethnicity and specimens contributed | Through study completion, an average of once per year |
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