Actively Recruiting

Age: 18Years +
All Genders
ID06046651

Blood Specimen Collection for Laboratory Assay Research to Evaluate Capillary and Venous Blood Sample Stability and Correlation

Led by Roman Health Ventures Inc. · Updated on 2024-11-14

10000

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how blood samples collected through fingerstick (capillary) compare to traditional venous blood samples for lab testing. This observational study aims to understand the stability of capillary blood samples under different environmental conditions and over time to support the development of lab procedures. The study addresses the need for easier, less distressing blood collection methods to expand diagnostic access and improve disease monitoring remotely. Participants may collect capillary blood themselves or have venous blood drawn by healthcare professionals at designated facilities or their homes. Capillary samples are collected via fingerstick using a lancet, with up to four samples per visit, while venous samples are collected through standard venipuncture methods. Samples are then processed and analyzed under various conditions such as temperature, humidity, light exposure, and freeze-thaw cycles to evaluate specimen stability and assay reliability. Participants provide blood samples either during a single visit or multiple visits over time until withdrawal or study end. The study includes collection of health information and consent, with compensation upon sample submission. Researchers will assess the correlation between capillary and venous samples and monitor sample stability over several days. The study is designed with minimal risk, involving routine procedures and safety monitoring, continuing until study closure or participant withdrawal.

CONDITIONS

Brief Title

Blood Specimen Collection For Laboratory Assay Research

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Any gender, in good general health
  • Must be 18 years old or older, inclusive at enrollment
  • Must be willing to provide capillary blood samples via a fingerstick and venous blood samples, including self-collection and collection by a licensed healthcare professional
  • Must be able to read, understand, and willingly sign an Informed Consent Form (ICF) and complete a brief health questionnaire
  • Must be able to read, speak and understand English
  • Must be available to attend one study visit at Investigator's laboratory or a third-party laboratory designated by the Investigator or collect samples at home, at the discretion of the Investigator.
Not Eligible

You will not qualify if you...

  • Individuals who are unable to provide a blood sample due to any illness
  • Individuals participating in another research study that may compromise study outcomes
  • Individuals having an acute or chronic disease or medical condition, including pregnancy, which could increase study risk or compromise outcomes
  • Individuals who are unlikely to be available for the duration of the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (electronic form and informed consent)

Sample Collection

Duration - Flexible; participants may provide a single sample or multiple samples over time until withdrawal or study closure

Participants provide blood samples which may be self-collected at home or collected by a licensed healthcare professional at a designated facility. Samples include capillary (fingerstick) and venous blood draws for laboratory research.

1 visit per 24-hour period, with multiple visits possible depending on participant choice

Trial Site Locations

Total: 1 location

1

Roman Health Ventures Study Site

San Francisco, California, United States, 94107

Actively Recruiting

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Research Team

N

Nitin Vaswani, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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