Age-Related Macular DegenerationNCT05635266
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
An observational study of Age-Related Macular Degeneration and Allergies, run by Sanguine Biosciences at 1 site in United States.
Trial summary
To collect, preserve, and/or distribute annotated 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 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration, Allergies, Alpha-Gal Syndrome
- What is being tested?
- Specimen sample
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2021to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health condition, exceptive condition, and control participants will be recruited by one or any of the following resources, but not limited to: * Use of online marketing where potential participants receive study information from the Sanguine's website or online participant referral program; * In the site investigators (or PI's) clinic; and/or * Through community advocacy programs. * Participant Referral
Who may be able to join
- Persons 18 to 85 years of age at the date of informed consent.
- If presenting with a history of a specific condition, the diagnosis is confirmable in the medical record or may be confirmed using other forms of verification including self-reporting.
- Understands the procedures and requirements of the study by providing written informed consent (or verbal assent if a legally authorized representative will sign the ICF), including consent for authorization for protected health information disclosure.
Who cannot join
- Persons younger than 18 years of age or older than 85 years of age at the date of informed consent.
- Receipt of blood products 30 days before the study blood draw.
- Receipt of an investigational (unapproved) drug 30 days before the study blood draw.
- A confirmable diagnosis of any medical condition that would increase potential phlebotomy risks.
- Has donated a unit of blood within the last 2 months at the date of informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sanguine Biosciences
Waltham, Massachusetts, 02451
About this study
Official title: A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
To collect, preserve, and/or distribute annotated 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.
- Conditions
- Age-Related Macular Degeneration, Allergies, Alpha-Gal Syndrome, Alzheimer Disease, Amyloidosis, Ankylosing Spondylitis
- Being tested
- Specimen sample
- Medical subject headings
- Macular Degeneration, Hypersensitivity, red meat allergy, Alzheimer Disease, Amyloidosis, Spondylitis, Ankylosing, Arthritis, Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen sampleDiagnostic test
The study may require a tissue collection and/or a participant survey for participation. Most tissue collected will come from a blood draw; up to 100mL for the health condition group, 60mL for the exceptive condition group, and up to 180mL for the control group (if determined safe for the participant). Participant surveys may involve participant reported outcomes (PROs) or custom participant surveys.
| Study group | Role | What they receive |
|---|---|---|
| Health Condition Group | Not described Receives: Diagnostic Test: Specimen sample | |
| Exceptive Condition Group | Not described Receives: Diagnostic Test: Specimen sample | |
| Control Group | Not described Receives: Diagnostic Test: Specimen sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biospecimen & Clinical Data Collection
To collect enough biospecimens and associated clinical data to allow researchers to come to statistically relevant scientific results
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start26 Oct 2021
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies 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
- Investigators
- Houman Hemmati, MD, Principal investigator, Sanguine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635266
- Sponsor's protocol ID
- SAN-BB-02
- Status last verified
- May 2024
- First submitted
- 22 Nov 2022
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
- ClinicalTrials.gov ID
- NCT05635266
- Acronym / sponsor ID
- SAN-BB-02
- Conditions
- Age-Related Macular Degeneration, Allergies, Alpha-Gal Syndrome, Alzheimer Disease, Amyloidosis, Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Sanguine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 2 Dec 2022 (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/or distribute annotated 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health Condition Group | – | Diagnostic Test: Specimen sample |
| Exceptive Condition Group | – | Diagnostic Test: Specimen sample |
| Control Group | – | Diagnostic Test: Specimen sample |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health condition, exceptive condition, and control participants will be recruited by one or any of the following resources, but not limited to: * Use of online marketing where potential participants receive study information from the Sanguine's website or online participant referral program; * In the site investigators (or PI's) clinic; and/or * Through community advocacy programs. * Participant Referral
Key inclusion criteria (3 listed)
- Persons 18 to 85 years of age at the date of informed consent.
- If presenting with a history of a specific condition, the diagnosis is confirmable in the medical record or may be confirmed using other forms of verification including self-reporting.
- Understands the procedures and requirements of the study by providing written informed consent (or verbal assent if a legally authorized representative will sign the ICF), including consent for authorization for protected health information disclosure.
Key exclusion criteria (5 listed)
- Persons younger than 18 years of age or older than 85 years of age at the date of informed consent.
- Receipt of blood products 30 days before the study blood draw.
- Receipt of an investigational (unapproved) drug 30 days before the study blood draw.
- A confirmable diagnosis of any medical condition that would increase potential phlebotomy risks.
- Has donated a unit of blood within the last 2 months at the date of informed consent.
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 |
|---|---|---|
| Specimen sampleThe study may require a tissue collection and/or a participant survey for participation. Most tissue collected will come from a blood draw; up to 100mL for the health condition group, 60mL for the exceptive condition group, and up to 180mL for the control group (if determined safe for the participant). Participant surveys may involve participant reported outcomes (PROs) or custom participant surveys. | Diagnostic test | Control Group, Exceptive Condition Group, Health Condition Group |
Primary outcome
Biospecimen & Clinical Data Collection
Time frame: 10 years
To collect enough biospecimens and associated clinical data to allow researchers to come to statistically relevant scientific results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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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. This study is not recruiting at the moment.
Houman Hemmati, MD principal investigator
Sanguine Biosciences
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 Age-Related Macular Degeneration and Allergies, 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Bidwell (855.836.4759, study@sanguinebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biospecimen & Clinical Data Collection (time frame: 10 years). 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 7 May 2024.