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Trial Title:
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
NCT ID:
NCT05635266
Condition:
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
Conditions: Official terms:
Hepatitis A
Spondylitis
Hidradenitis Suppurativa
Myasthenia Gravis
Fibromyalgia
Spondylitis, Ankylosing
Hepatitis
Cystic Fibrosis
Crohn Disease
Celiac Disease
Hepatitis, Autoimmune
Behcet Syndrome
Parkinson Disease
Multiple Sclerosis
Alzheimer Disease
Epilepsies, Myoclonic
Macular Degeneration
Graves Disease
Kidney Diseases
Vasculitis
Anemia, Sickle Cell
Thalassemia
beta-Thalassemia
Dermatitis
Alopecia
Vitiligo
Hidradenitis
Alopecia Areata
Pemphigus
Amyloidosis
Thyroid Diseases
Syndrome
Schizophrenia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Specimen sample
Description:
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.
Arm group label:
Control Group
Arm group label:
Exceptive Condition Group
Arm group label:
Health Condition Group
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Sanguine Biosciences
Address:
City:
Waltham
Zip:
02451
Country:
United States
Status:
Recruiting
Start date:
October 26, 2021
Completion date:
October 2025
Lead sponsor:
Agency:
Sanguine Biosciences
Agency class:
Industry
Source:
Sanguine Biosciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05635266