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

Primary Purpose

Age-Related Macular Degeneration, Allergies, Alpha-Gal Syndrome

Status
Recruiting
Phase
Locations
United States
Study Type
Observational
Intervention
Specimen sample
Sponsored by
Sanguine Biosciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Age-Related Macular Degeneration

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sanguine BiosciencesRecruiting

Outcomes

Primary Outcome Measures

Biospecimen & Clinical Data Collection
To collect enough biospecimens and associated clinical data to allow researchers to come to statistically relevant scientific results

Secondary Outcome Measures

Full Information

First Posted
November 22, 2022
Last Updated
November 22, 2022
Sponsor
Sanguine Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT05635266
Brief Title
A Single-Site 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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanguine Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Enrollment
20000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Specimen sample
Intervention 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.
Primary Outcome Measure Information:
Title
Biospecimen & Clinical Data Collection
Description
To collect enough biospecimens and associated clinical data to allow researchers to come to statistically relevant scientific results
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Study Population Description
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolyn Bidwell
Phone
855.836.4759
Email
study@sanguinebio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Houman Hemmati, MD
Organizational Affiliation
Sanguine Biosciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanguine Biosciences
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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