AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

Audubon Bioscience

Status: Invitation-only

Conditions: Hematologic Malignancy; Oncology; Pregnancy Related; Gastro-Intestinal Disorder; Cardiovascular Diseases; Renal Disease; Genitourinary Disease; Infectious Disease; Autoimmune Diseases

Treatments: Other: Observational Study Only. NO Intervention.

Study type: Observational

Funder types: Industry

Identifiers

NCT05889806

US005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

10,000 participants in 2 patient groups

Healthy

Description:

Healthy subjects with no history of chronic disease

Treatment:

Other: Observational Study Only. NO Intervention.

Subjects with various conditions

Description:

Subjects that have been diagnosed with a condition of interest such as Diabetes, NASH, Breast Cancer, Endometriosis, or other designated condition.

Treatment:

Other: Observational Study Only. NO Intervention.