|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 NOW**
First Posted : December 2, 2022
Last Update Posted : December 2, 2022
Information provided by (Responsible Party):
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.
|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 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|
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
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
- 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.
- 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.
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
|Waltham, Massachusetts, United States, 02451|
|Principal Investigator:||Houman Hemmati, MD||Sanguine Biosciences|
|Responsible Party:||Sanguine Biosciences|
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Additional relevant MeSH terms:
Anemia, Sickle Cell
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By 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.