Collection and distribution of leukopak biospecimens for biomedical research
A Multi-Site Leukopak Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives
This study is collecting blood samples and health information from up to 20,000 people to help researchers with various medical studies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Sanguine Biosciences Industry-sponsored |
| Locations | 1 site (Waltham, Massachusetts) |
| Trial ID | NCT05794217 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect, preserve, and distribute annotated leukopak biospecimens along with associated medical data for approved biomedical research initiatives. It involves up to 20,000 participants who will undergo a screening visit and an apheresis visit to collect the biospecimens. The collected samples will be processed and stored, with the option to be delivered frozen or unfrozen to researchers in an anonymized manner. The study emphasizes informed consent and the collection of health information through self-report and medical record review.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals aged 18 to 89 who meet specific health criteria for the apheresis procedure.
Not a fit: Patients who are younger than 18 or older than 89 years, or those who do not meet the health criteria for apheresis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could significantly enhance the development of new treatments and diagnostics for rare diseases.
How similar studies have performed: While similar biospecimen collection initiatives have been conducted, this specific approach to collecting leukopak biospecimens for rare diseases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persons deemed healthy enough for the procedure and aged 18 to 89 years at the date of informed consent. Minimum weight of 110 lbs. Pulse greater than 50 and less than 110 beats per minute Blood Pressure diastolic greater than 50 mmHg and less than100 mmHG and systolic is greater than 90 mmHg and less than 180 mmHg Peripheral veinous access is deemed adequate for apheresis as determined by apheresis staff. Negative for Hepatitis B, Hepatitis C, and HIV 1-2 upon testing performed within 30 days, unless specifically obtaining cell collection based upon this diagnosis. CBC results which fall within site-specific parameters within 30 days of apheresis procedure: The participant understands the procedures and requirements of the study by providing written informed consent, including consent for authorization for protected health information disclosure. Exclusion Criteria: * Persons younger than 18 years of age or older than 89 years of age at the date of informed consent. Presenting with a history of a specific condition determined through medical evaluation to be incompatible with safely undergoing apheresis Receipt of transfusion of blood products within 30 days of the study procedure. Receipt of an investigational (unapproved) drug 30 days before the study procedure. A confirmable diagnosis of any medical condition that would increase potential procedure risks. Such medical conditions include: Severe or untreated cardiovascular, kidney, liver, or lung diseases which would preclude apheresis procedures; Bleeding disorders Conditions associated with chronic anemia Active systemic infection Use of ACE inhibitors unless they can safely be held for 24 hours prior to apheresis procedure Pregnancy Has donated a unit of blood within the last 2 months at the date of informed consent. Unable to understand the procedures and requirements of the study in order to provide written informed consent, including consent for authorization for protected health information disclosure. Requires a Legally Authorized Representative (LAR) for the study informed consent.
Where this trial is running
Waltham, Massachusetts
- Sanguine Biosciences — Waltham, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.