AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

Trial Title: AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

NCT ID: NCT05889806

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

Conditions: Official terms:
Communicable Diseases
Infections
Hematologic Neoplasms
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urogenital Diseases
Cardiovascular Diseases
Autoimmune Diseases

Study type: Observational

Overall status: Enrolling by invitation

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Observational Study Only. NO Intervention.
Description: Observational Study Only. NO Intervention.
Arm group label: Healthy
Arm group label: Subjects with various conditions

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.

Criteria for eligibility:

Study pop:
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
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: AUD

Address:
City: New Orleans
Zip: 70112
Country: United States

Start date: May 10, 2023

Completion date: June 10, 2043

Lead sponsor:
Agency: Audubon Bioscience
Agency class: Industry

Source: Audubon Bioscience

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05889806