Rare DiseasesNCT05794217
A Multi-Site Leukopak Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives
An observational study of Rare Diseases, run by Sanguine Biosciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Rare Diseases
- What is being tested?
- This is a non-interventional study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sanguine Biosciences
Waltham, Massachusetts, 02451
Sonia Lunar, 855-836-4759, slunar@sanguinebio.com
Timothy Triche, MD
About this study
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.
Read the detailed 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
- Conditions
- Rare Diseases
- Being tested
- This is a non-interventional study
- Medical subject headings
- Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a non-interventional studyBehavioural
This is a non-interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukopak
The studies collected biospecimens are white blood cells, specifically leukopaks.
Measured: September 2022 and September 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start28 Sep 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanguine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794217
- Sponsor's protocol ID
- SAN-BB-LEUK-01
- Status last verified
- Dec 2024
- First submitted
- 20 Mar 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared with researchers via redacted medical records.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Leukopak Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives
- ClinicalTrials.gov ID
- NCT05794217
- Acronym / sponsor ID
- SAN-BB-LEUK-01
- Conditions
- Rare Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Sanguine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a non-interventional studyThis is a non-interventional study | Behavioural | – |
Primary outcome
Leukopak
Time frame: September 2022 and September 2024
The studies collected biospecimens are white blood cells, specifically leukopaks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared with researchers via redacted medical records.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rare Diseases, run by Sanguine Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukopak (time frame: September 2022 and September 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.