ClinicalTrials.gg
RecruitingNCT05635266Updated May 7, 2024

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

An observational study in Age-Related Macular Degeneration, Allergies and Alpha-Gal Syndrome, sponsored by Sanguine Biosciences. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by Sanguine Biosciences · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Oct 2021; still recruiting 5 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20,000
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 110 across 409 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Sanguine Biosciences is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Persons 18 to 85 years of age at the date of .
  • 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

Exclusion Criteria:

  • Persons younger than 18 years of age or older than 85 years of age at the date of .
  • Receipt of blood products 30 days before the study blood draw.
  • Receipt of an (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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Health Condition Group

    Diagnostic Test: Specimen sample

  • Exceptive Condition Group

    Diagnostic Test: Specimen sample

  • Control Group

    Diagnostic Test: Specimen sample

Interventions

  • Diagnostic testSpecimen 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.

06

What researchers measure

Primary outcomes

  1. Biospecimen & Clinical Data Collection

    To collect enough biospecimens and associated clinical data to allow researchers to come to statistically relevant scientific results

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05635266
Lead sponsor
Sanguine Biosciences
Responsible party
Sponsor
First posted
Dec 2, 2022
Start date
Oct 26, 2021
Primary completion
Oct 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
May 7, 2024

Study contacts

Carolyn Bidwell
Contact
study@sanguinebio.com
855.836.4759
Houman Hemmati, MD
principal investigator · Sanguine Biosciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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