AUD Biomarkers Study (Proteomic and Genomic Analysis of B... | NCT05889806

Studies
AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

NCT05889806

Sponsor

Audubon Bioscience

Status

Enrolling by invitation

Last Update Posted

Jun 5, 2023Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

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

Interventions

Observational Study Only. NO Intervention.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2023Actual

Primary Completion Date

May 10, 2043Estimated

Completion Date

Jun 10, 2043Estimated

First Submitted Date

May 25, 2023

First Submission Date that Met QC Criteria

Jun 2, 2023

First Posted Date

Jun 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2023

Last Update Posted Date

Jun 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy		Healthy subjects with no history of chronic disease	Other: 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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational Study Only. NO Intervention.	Other	Observational Study Only. NO Intervention.	Healthy Subjects with various conditions

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
AUD		New Orleans	Louisiana	70112	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Description

This Study will collect leftover Specimens that are taken during standard medical care procedures (for example, tissues, whole teeth, blood, saliva, urine, fluids, and cells). Samples will first be processed for clinical purposes, and any discarded portions of the Specimen(s) will be provided to the Sponsor for the Study purposes.

Non-Surplus Specimens Types to be Collected for Study:

Blood Tooth Bone marrow aspirate Aqueous humor Urine Perineal specimens Rectal specimens Urethral specimens Nasal/Nasopharyngeal and throat specimens Cheek (buccal) specimens Saliva (Sputum) Oral rinse Stool samples Vaginal and cervical specimens Endometrial (uterus) samples Vaginal lavage (wash)

ID	Term
D009369	Neoplasms
D019337	Hematologic Neoplasms
D004066	Digestive System Diseases
D001327	Autoimmune Diseases
D003141	Communicable Diseases
D002318	Cardiovascular Diseases
D000091642	Urogenital Diseases
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007154	Immune System Diseases
D007239	Infections
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D052801	Male Urogenital Diseases