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

NCT ID: NCT05635266

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-26

Study Completion Date

2025-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Health Condition Group

Specimen sample

Intervention Type DIAGNOSTIC_TEST

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.

Exceptive Condition Group

Specimen sample

Intervention Type DIAGNOSTIC_TEST

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.

Control Group

Specimen sample

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanguine Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Houman Hemmati, MD

Role: PRINCIPAL_INVESTIGATOR

Sanguine Biosciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sanguine Biosciences

Waltham, Massachusetts, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Carolyn Bidwell

Role: CONTACT

855.836.4759

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAN-BB-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Thoracic Specimen Registry
NCT04118660 RECRUITING