AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

NCT05889806 | Enrolling By Invitation

• 1 other identifier: US005
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Observational Study Only. NO Intervention. OTHER

Observational Study Only. NO Intervention.

Healthy; Subjects with various conditions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 be able to donate the requested Specimen(s) without compromising his/her current health status.

You may not qualify if:

• 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

Sponsors & Collaborators

• Audubon Bioscience: lead

Study Sites (1)

AUD

New Orleans, Louisiana, 70112, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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)

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms; Digestive System Diseases; Autoimmune Diseases; Communicable Diseases; Cardiovascular Diseases; Urogenital Diseases; Kidney Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 5, 2023
• Study Start: May 10, 2023
• Primary Completion (Estimated): May 10, 2043
• Study Completion (Estimated): June 10, 2043
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)