RecruitingNCT05635266

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

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


Sponsor

Sanguine Biosciences

Enrollment

20,000 participants

Start Date

Oct 26, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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.

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.


Locations(1)

Sanguine Biosciences

Waltham, Massachusetts, United States

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NCT05635266


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