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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05635266
Recruitment Status : Recruiting
First Posted : December 2, 2022
Last Update Posted : December 2, 2022
Sponsor:
Information provided by (Responsible Party):
Sanguine Biosciences

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
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 Diagnostic Test: Specimen sample

Study Design
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Study Type : Observational
Estimated Enrollment : 20000 participants
Official Title: A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Actual Study Start Date : October 26, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Biospecimen & Clinical Data Collection [ Time Frame: 10 years ]
    To collect enough biospecimens and associated clinical data to allow researchers to come to statistically relevant scientific results


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05635266


Contacts
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Contact: Carolyn Bidwell 855.836.4759 study@sanguinebio.com

Locations
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United States, Massachusetts
Sanguine Biosciences Recruiting
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Sanguine Biosciences
Investigators
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Principal Investigator: Houman Hemmati, MD Sanguine Biosciences
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Sanguine Biosciences
ClinicalTrials.gov Identifier: NCT05635266    
Other Study ID Numbers: SAN-BB-02
First Posted: December 2, 2022    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pemphigus
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
Amyloidosis