Clinical trial NCT05889806: AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)
Official title: AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens Involved in Diseases and Healthy Populations)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Oncology
Hematologic Malignancy
Gastro-Intestinal Disorder
Autoimmune Diseases
Pregnancy Related
Infectious Disease
Cardiovascular Diseases
Genitourinary Disease
Renal Disease
Lead sponsor: Audubon Bioscience
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include willing participants that are able to provide consent (or have an LAR to provide consent on their behalf), the requested biospecimens and associated data.

Brief summary: 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.

Detailed description: The primary objective of this Study is to collect high-quality tissue, whole teeth, and biofluid Specimens, and associated Clinical Data from consented Subjects.

The secondary objective of this Study is to test Specimens and associated Clinical Data to confirm pathology diagnosis and correlation of microscopic evaluation with the provided information, to assess RNA and DNA integrity or degradation, and provide overall quality control evaluations.

Eligibility criteria: 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

Primary outcomes:
measure: Enrollment and collection totals for a diverse population of subjects/conditions involved in diseases and in healthy/control populations.
timeFrame: Through study completion, an average of once per year
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: AUD
state: Louisiana
Study officials:
References: