Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06046651 |
| Other study ID # |
RS.0723.012 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 16, 2023 |
| Est. completion date |
August 15, 2033 |
Study information
| Verified date |
September 2023 |
| Source |
Roman Health Ventures Inc. |
| Contact |
Nitin Vaswani, MD |
| Phone |
7577263449 |
| Email |
nitin.vaswani[@]ro.co |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To collect lab data from capillary and venous blood specimens for use in analytical research
studies to support the development and validation of laboratory procedures.
Description:
Introduction Overview Remote health monitoring is becoming more commonplace in traditional
and non-traditional medical practices, including for the analysis of blood. As venipuncture
processes may cause distress and lead to lower patient compliance, the ability to collect
blood through capillary samples is becoming increasingly popular due to patient demand and
the limited availability of phlebotomists. With recent advances in lab instrumentation, the
ability to analyze small volumes of blood to support the diagnostic process is gradually
becoming more established.
Despite the development of several novel devices to collect capillary samples, limited data
is available on the stability of such samples across various environmental conditions and
lengths of time. In addition, there continues to be a need to compare the correlation between
lab results obtained from capillary samples, as compared to venous samples, which is the gold
standard. The aim of this study is to collect capillary (fingerstick) blood samples and under
various circumstances, assess their viability for broad-based consumer lab testing.
Background Traditionally, clinical lab results have been limited to data collected from
select sites that have phlebotomists on-site. While valuable, these diagnostic services are
only available to individuals who live close enough to a lab, thereby limiting our
understanding of disease within the broader community. Lab visits are limited to very
specific episodes of care, which exclude the ability to remotely monitor the progression of
disease. In addition, these limited lab visits usually only study a small set of assays
within each individual, biasing our understanding of any other underlying medical conditions
that exist within a population. The need to develop technology to make diagnostic services
more accessible is paramount to not only better treat acute and chronic diseases, but to also
support behavioral change toward the prevention of disease.
At-home blood collection for lab testing has become increasingly popular to monitor disease
and access treatments more rapidly. The ability to broaden access to diagnostic testing,
especially in healthcare deserts, is valuable to mitigating the progression of disease. For
example, clinicians will have access to a higher volume of lab data and be able to identify
disease patterns more readily, which may lead to quicker intervention. On a population health
level, improved access to diagnostics will provide insights into patient behavior and
underlying disease states that may otherwise not be observed.
Empowering patients to collect their own samples will provide a longitudinal view of disease,
and enable deeper discussions with their clinicians regarding appropriate treatment and
lifestyle changes.
Study Design This is an internal observational study, non-interventional.
Methods Sample Collection and Handling Specimens will either be self-collected by the subject
(capillary samples) or collected by a licensed healthcare professional (capillary or venous
samples) at the investigator's wholly-owned facility or a subject's home. Specimens will be
stored or transported to one of the investigator's laboratories, a third-party laboratory, or
a research facility for use in analytical research studies.
Subjects may elect to provide a single sample, or continue providing samples on a regular
basis until the subject withdraws from the study, is removed from the study, or the study is
closed. Study visits are limited to 1 visit per 24 hour period.
Specimen Type and Collection Methods Specimen Collection Method Capillary Blood Capillary
blood will be collected from a finger using a standard lancet, by the subject independently
or with the assistance of a licensed healthcare professional.
Collection instructions, following consent:
Either independently, or under the direction of research staff, apply a hand warmer on the
desired finger or run the finger under warm water for 1 minute. Dry finger. Clean skin with
an alcohol wipe, and allow the alcohol to dry. Apply lancet to finger. Drip blood into a
specified collection container, which may be a capillary tube or other blood transfer device.
Notwithstanding any other specimen collections described in this protocol, a maximum of 4
capillary blood draws may be collected in one visit (less than 4 mL total).
At-home kit:
When subjects collect their own samples off-site, all necessary containers, materials, and
instructions for shipping will be included in the original collection kit. Shipment will be
designed to comply with packaging associated with "Exempt human specimen."
Shipment preparation procedure will be as follows: Sample is placed in a sealed primary
receptacle (tube, vial, container), then secondary packaging (cushioning and absorbent
materials), and then into outer packaging.
Venous Blood Venous blood will be collected from the antecubital fossa, forearm, or hand of
the subject by a licensed health professional: phlebotomist, physician, nurse, or physician
assistant. This collection may occur on-site at the investigator's facility, the subject's
home or office, or at any location that is appropriate and convenient.
Collection instructions, following consent:
The investigators will obtain consent from the subject and schedule the subject for
phlebotomy at a specific time and site. The healthcare professional performing the specimen
collection will confirm with the subject that the subject has provided consent, and confirms
that the subject understands that the blood collection will be for research purposes,
including for commercial product development, and not for the purpose of diagnosis or
treatment. The subject's name and date of birth will be confirmed by the healthcare
professional. Additional personal health and demographic information may be collected at this
time or any other time during the visit.
Venipuncture: The arm will be prepared with a tourniquet and disinfected with an alcohol pad.
Up to 5 tubes (approximately 25 mL) of blood may be collected. After the application of
sterile gauze, the needle will then be removed and pressure maintained for at least 1 minute.
Following visual examination for any side effects, the venipuncture site will be dressed with
a bandage on top of the gauze to apply mild pressure to the venipuncture site. Alternatively,
pressure will be maintained for at least 3 minutes with gauze, followed by the application of
a self-adhesive bandage.
Sample Processing Blood specimens collected under this protocol will be processed to assess
specific study endpoints intended to support the development and validation of laboratory
assays and procedures.
Variables of interest may include but are not limited to Temperature Variations: The aliquots
may be subjected to different temperature ranges representative of real-life situations, such
as refrigerated (2-8°C), room temperature (20-25°C), and elevated temperatures (e.g., >
37°C). Some stability studies might also include extreme temperatures to assess how the
sample performs under stress conditions.
Time Points: Each aliquot may be assessed at multiple time points to evaluate the stability
of the specimen over time. Common time points for stability testing could be 0 hours
(baseline), 24 hours, 48 hours, 72 hours, and so on, depending on research objectives.
Component Separation: Depending on the type of research being conducted, the blood specimens
may undergo component separation. This process involves centrifugation to separate the
different blood components - plasma, serum, and cellular elements (red and white blood
cells). This separation allows the individual components to be analyzed independently,
providing valuable insights into how each component behaves during research.
Humidity: Assessing the impact of varying levels of humidity on blood specimen stability,
especially in climates with high moisture content.
Light Exposure: Investigating how exposure to different light conditions (e.g., natural
light, fluorescent light) might influence the stability of certain analytes in the blood.
Freeze-Thaw Cycles: Replicating scenarios where specimens experience repeated freezing and
thawing to evaluate the effects on sample integrity.
Anticoagulants and Additives: Exploring the impact of different anticoagulants or additives
on specimen stability to optimize blood collection tubes and preservation methods.
Shipping and Transportation Conditions: Studying the stability of blood specimens during
transit and evaluating the impact of varying transportation conditions.
Specimen Volume: Investigating whether different specimen volumes influence stability and
testing accuracy.
Freezer or Fridge Storage: Examining the stability of blood specimens under long-term
refrigerated or freeze storage conditions (e.g., -20°C, -80°C).
pH and Buffering Conditions: Assessing the role of pH and buffering systems in maintaining
the stability of blood components.
Hemolysis and Clot Formation: Investigating the impact of hemolysis and clot formation on
test results and evaluating their effects on specimen stability.
The list of variables mentioned above is not exhaustive, and additional factors may be
considered based on the specific objectives of the research study.
Procedure Screening / Consent Potential subjects will complete screening using an electronic
form, including a brief medical history. Potential subjects will undergo informed consent.
Sample Collection Subjects will attend the study visit at the clinic to have blood samples
collected OR Subjects will self-collect samples at home following provided instructions and
ship samples to the designated laboratory.
Upon completion of sample collection, subjects will be compensated for their participation
and dismissed from the study visit. Subjects may choose to remain enrolled in the study and
participate in future study visits, or withdraw from study participation at any time.
Potential Risks and Benefits This research falls under a minimal risk category. The
probability of harm or discomfort is comparable to routine clinical examination. All specimen
collection is routine with minimal risk of persistent bleeding or infection. There are no
direct benefits to the subjects. Research performed based on the collected samples may lead
to advances in medical research and commercial (for-profit) products with societal benefits.
