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

Sponsor

Sanguine Biosciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05635266

Collaborator

(none)

20,000

Enrollment

Location

23.2

Anticipated Duration (Months)

863.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration Allergies Alpha-Gal Syndrome Alzheimer Disease Amyloidosis Ankylosing Spondylitis Arthritis Alopecia Areata Asthma Atopic Dermatitis Autism Autoimmune Hepatitis Behcet's Disease Beta-Thalassemia Cancer Celiac Disease Kidney Diseases COPD Crohn Disease Cystic Fibrosis Diabetes Dravet Syndrome DMD Fibromyalgia Graves Disease Thyroid Diseases Hepatitis Hidradenitis Suppurativa ITP Leukemia ALS Lupus or SLE Lymphoma Multiple Sclerosis Myasthenia Gravis Heart Diseases Parkinson Disease Pemphigus Vulgaris Cirrhosis Psoriasis Schizophrenia Scleroderma Sickle Cell Disease Stroke Ulcerative Colitis Vasculitis Vitiligo	Diagnostic Test: Specimen sample

Study Design

Study Type:

Observational

Anticipated Enrollment :

20000 participants

Official Title:

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

Actual Study Start Date :

Oct 26, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.