AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational Study Only. NO Intervention..
- Who it may be relevant to
- Registry conditions: Oncology, Hematologic Malignancy, Gastro-Intestinal Disorder, Autoimmune Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens Involved in Diseases and Healthy Populations)
Overview
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.
Interventions
- Other Observational Study Only. NO Intervention.
Observational Study Only. NO Intervention.
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- AUD — New Orleans
Identifiers
NCT: NCT05889806 · US005