Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives

Recruiting

• Conditions: Ankylosing Spondylitis; Atopic Dermatitis; Age-Related Macular Degeneration; Alzheimer Disease; Amyloidosis; Asthma; Autoimmune Hepatitis; Behcet's Disease; Dravet Syndrome; DMD
• Interventions: Diagnostic Test: Specimen sample

• Registration Number: NCT05635266
• Lead Sponsor: Sanguine Biosciences

Brief Summary

To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-26
• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-11-22
• Study First Posted: 2022-12-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-07
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• Persons 18 to 85 years of age at the date of informed consent.
• If presenting with a history of a specific condition, the diagnosis is confirmable in the medical record or may be confirmed using other forms of verification including self-reporting.
• Understands the procedures and requirements of the study by providing written informed consent (or verbal assent if a legally authorized representative will sign the ICF), including consent for authorization for protected health information disclosure.

Exclusion Criteria

• Persons younger than 18 years of age or older than 85 years of age at the date of informed consent.
• Receipt of blood products 30 days before the study blood draw.
• Receipt of an investigational (unapproved) drug 30 days before the study blood draw.
• A confirmable diagnosis of any medical condition that would increase potential phlebotomy risks.
• Has donated a unit of blood within the last 2 months at the date of informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health Condition Group	Specimen sample	-
Exceptive Condition Group	Specimen sample	-
Control Group	Specimen sample	-

Primary Outcome Measures

Name	Time	Method
Biospecimen & Clinical Data Collection	10 years	To collect enough biospecimens and associated clinical data to allow researchers to come to statistically relevant scientific results

Trial Locations

Locations (1)

Sanguine Biosciences; 🇺🇸 Waltham, Massachusetts, United States