Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
Study NCT ID:
NCT05889806
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-06-05
First Post:
2023-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)
Sponsor:
Audubon Bioscience
Organization:
Study Overview
Official Title:
AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens Involved in Diseases and Healthy Populations)
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: