AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

Sponsor

Audubon Bioscience (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05889806

Collaborator

(none)

10,000

Enrollment

Location

241

Anticipated Duration (Months)

41.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oncology Hematologic Malignancy Gastro-Intestinal Disorder Autoimmune Diseases Pregnancy Related Infectious Disease Cardiovascular Diseases Genitourinary Disease Renal Disease	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 Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 10, 2023

Anticipated Primary Completion Date :

May 10, 2043

Anticipated Study Completion Date :

Jun 10, 2043

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Enrollment and collection totals for a diverse population of subjects/conditions involved in diseases and in healthy/control populations. [Through study completion, an average of once per year]
We will total the number of subjects and characterize the totals by disease state, gender, ethnicity and specimens contributed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subject shall be at least 18 years of age, or higher if required by Applicable Law.
Subject's Clinical Data shall be relevant to the Study in which he/she is participating.
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).
Subject shall meet any other additional inclusion criteria specified in Appendices to this Protocol, or in additional written instructions of the Sponsor.
Subject shall be able to donate the requested Specimen(s) without compromising his/her current health status.

Exclusion Criteria:

Younger than 18 years of age, or higher if required by Applicable Law.
The individual is incapable of understanding the items listed in the ICF and the consent process unless consented by the legally authorized representative.
Prisoner