AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Observational Study Only. NO Intervention.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>Healthy subjects with no history of chronic disease | Other: Observational Study Only. NO Intervention.<br>* Observational Study Only. NO Intervention.<br>|
| Subjects with various conditions<br>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.<br>* Observational Study Only. NO Intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |