Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05794217 |
Other study ID # |
SAN-BB-LEUK-01 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 28, 2022 |
Est. completion date |
September 28, 2024 |
Study information
Verified date |
April 2024 |
Source |
Sanguine Biosciences |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
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.
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