Collection and distribution of leukopak biospecimens for biomedical research

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sanguine Biosciences
  Waltham, Massachusetts, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.