AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

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.

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Key information

Conditions

Oncology Autoimmune Diseases Cardiovascular Diseases Communicable Diseases Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastro-Intestinal Disorder Genitourinary Disease Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Infections Infectious Disease Kidney Diseases Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Related Renal Disease Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AUD

New Orleans, Louisiana, 70112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Study Only. NO Intervention.

Other

Observational Study Only. NO Intervention.

Primary outcomes

Enrollment and collection totals for a diverse population of subjects/conditions involved in diseases and in healthy/control populations.

Time frame: 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

Sponsors and collaborators

Lead sponsor

Audubon Bioscience

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2043
Study completion: 2043
First posted: Jun 5, 2023
Registry last updated: Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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