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

Rare Diseases Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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.

The biospecimens collected by apheresis may be processed and stored, delivered frozen, or delivered unfrozen directly to the requesting researcher. All participant specimens, if processed, will be stored, and distributed to researchers in an anonymized fashion.

The following activities will occur during the study:

Sponsor Obtain overall study informed consent. Sanguine will implement a software-as-a-service (SaaS) provider of electronic signature technology and transaction management solutions and/or a hardcopy of the informed consent form (ICF). Participants may electronically sign the ICF and authorization of release of information using an electronic device. The Sponsor will also provide the participant the option of completing hardcopy documents if they so desire. In addition to the Principal Investigator (PI), approved study staff can also administer and sign the ICF and will address all of the participant's queries regarding the ICF and study design. The informed consent process can take place at the site location by the on-site staff. In addition to the overall study informed consent, sites may also administer their own ICF per site-specific procedures, if required.

Health information will be collected via self-report and medical record review to obtain a detailed clinical history of the subject's health. The health information includes but is not limited to demographic and lifestyle information, height and weight, current medications and comorbidities, date of diagnosis, condition-related treatment history, current disease characteristics, diagnostic reports, and family medical history.

Apheresis Center Laboratory tests, including, but not limited to, a complete blood count (CBC) and viral testing for hepatitis C, hepatitis B, and HIV, at a minimum, will be performed on all prospective donors.

Apheresis health questionnaire to identify potential health risks and risk of communicable disease.

Venous access check completed by an apheresis nurse to qualify donor as having adequate veins for successful apheresis.

Assessment performed by the apheresis collection center on the day of donation which may include (but is not limited to the following) Basic health questionnaire to assess donor suitability for apheresis Mini physical exam including vitals and hemoglobin measurement Other requirements of the apheresis center as per standard procedure Apheresis cell collection ;

Related Conditions & MeSH terms

• Rare Diseases

• NCT number: NCT05794217
• Study type: Observational
• Source: Sanguine Biosciences
• Status: Recruiting
• Start date: September 28, 2022
• Completion date: September 28, 2024