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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05635266
• Other study ID #: SAN-BB-02
• Status: Recruiting
• Start date: October 26, 2021
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: Sanguine Biosciences
• Contact: Carolyn Bidwell
• Phone: 855.836.4759
• Email: study[@]sanguinebio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Allergies
• Alopecia
• Alopecia Areata
• ALS
• Alzheimer Disease
• Amyloidosis
• Anemia, Sickle Cell
• Ankylosing Spondylitis
• Arthritis
• Asthma
• Atopic Dermatitis
• Autism
• Autoimmune Hepatitis
• Behcet Syndrome
• Behcet's Disease
• Beta-Thalassemia
• Cancer
• Celiac Disease
• Cirrhosis
• COPD
• Crohn Disease
• Cystic Fibrosis
• Dermatitis
• Diabetes
• DMD
• Dravet Syndrome
• Epilepsies, Myoclonic
• Fibromyalgia
• Graves Disease
• Heart Diseases
• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune
• Hidradenitis
• Hidradenitis Suppurativa
• ITP
• Kidney Diseases
• Leukemia
• Lymphoma
• Macular Degeneration
• Multiple Sclerosis
• Myasthenia Gravis
• Parkinson Disease
• Pemphigus
• Pemphigus Vulgaris
• Psoriasis
• Schizophrenia
• Scleroderma
• Sickle Cell Disease
• Spondylitis
• Spondylitis, Ankylosing
• Stroke
• Syndrome
• Thalassemia
• Thyroid Diseases
• Ulcerative Colitis
• Vasculitis
• Vitiligo

Intervention

Diagnostic Test:
• Specimen sample
The study may require a tissue collection and/or a participant survey for participation. Most tissue collected will come from a blood draw; up to 100mL for the health condition group, 60mL for the exceptive condition group, and up to 180mL for the control group (if determined safe for the participant). Participant surveys may involve participant reported outcomes (PROs) or custom participant surveys.

Locations

Country	Name	City	State
United States	Sanguine Biosciences	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Sanguine Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biospecimen & Clinical Data Collection	To collect enough biospecimens and associated clinical data to allow researchers to come to statistically relevant scientific results	10 years