Clinical trial NCT05635266: Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Official title: A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: Sanguine Biosciences
Sponsor class: INDUSTRY
First posted: 2022-12-02
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Health condition, exceptive condition, and control participants will be recruited by one or any of the following resources, but not limited to:

* Use of online marketing where potential participants receive study information from the Sanguine's website or online participant referral program;
* In the site investigators (or PI's) clinic; and/or
* Through community advocacy programs.
* Participant Referral

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Biospecimen & Clinical Data Collection
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Sanguine Biosciences
state: Massachusetts
Study officials:
affiliation: Sanguine Biosciences
name: Houman Hemmati, MD
role: PRINCIPAL_INVESTIGATOR
References: