A Multi-Site Leukopak Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives

NCT05794217 | Recruiting

• 1 other identifier: SAN-BB-LEUK-01
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

To collect, preserve, and distribute annotated leukopak 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. This protocol will be utilized to collect research grade products that are not meant for transfusion.

Conditions

Rare Diseases

Outcome Measures

Primary Outcomes (1)

• Leukopak

  The studies collected biospecimens are white blood cells, specifically leukopaks.

  September 2022 and September 2024

Interventions

This is a non-interventional study BEHAVIORAL

This is a non-interventional study

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a multi-center study, with up to 20,000 participants enrolled. Participants may complete up to two visits, a screening visit, and an apheresis visit, during their enrollment in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanguine Biosciences: lead

Study Sites (1)

Sanguine Biosciences

Waltham, Massachusetts, 02451, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The studies collected biospecimens are white blood cells, specifically leukopaks.

MeSH Terms

Conditions

Rare Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: September 28, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)