AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05889806
• Other study ID #: US005
• Status: Enrolling by invitation
• Start date: May 10, 2023
• Est. completion date: June 10, 2043

Study information

• Verified date: June 2023
• Source: Audubon Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: June 10, 2043
• Est. primary completion date: May 10, 2043
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Cardiovascular Diseases
• Communicable Diseases
• Digestive System Diseases
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Genitourinary Disease
• Hematologic Malignancy
• Hematologic Neoplasms
• Infections
• Infectious Disease
• Intestinal Diseases
• Oncology
• Pregnancy Related
• Renal Disease
• Urogenital Diseases

Intervention

Other:
• Observational Study Only. NO Intervention.
Observational Study Only. NO Intervention.

Locations

Country	Name	City	State
United States	AUD	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Audubon Bioscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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