AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens Involved in Diseases and Healthy Populations)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Diseases; Autoimmune Diseases; Infectious Disease; Pregnancy Related; Hematologic Malignancy; Oncology; Renal Disease; Gastro-Intestinal Disorder; Genitourinary Disease
• Intervention / Treatment: Other: Observational Study Only. NO Intervention.

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • AUD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy; Healthy subjects with no history of chronic disease	Other: Observational Study Only. NO Intervention.; Observational Study Only. NO Intervention.
Subjects with various conditions; Subjects that have been diagnosed with a condition of interest such as Diabetes, NASH, Breast Cancer, Endometriosis, or other designated condition.	Other: Observational Study Only. NO Intervention.; Observational Study Only. NO Intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Audubon Bioscience

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): May 10, 2043
• Study Completion (Estimated): June 10, 2043

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Hematologic Diseases; Cardiovascular Diseases; Hematologic Neoplasms; Infections; Communicable Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Autoimmune Diseases; Urogenital Diseases
• Other Study ID Numbers: US005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No