Blood Specimen Collection For Laboratory Assay Research

NCT06046651 | Recruiting

• 1 other identifier: RS.0723.012
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General; Metabolic Disorder; Sexual Dysfunction; Hair Loss; Pathology

Outcome Measures

Primary Outcomes (2)

• Correlation between capillary and venous samples upon collection

  R-value comparing the lab readings generated by venous and capillary samples for a specific blood analyte immediately upon collection

  10 years

• Stability of the capillary blood sample after storage on Days 1, 2, and 3

  Median error % to compare the difference in values of each capillary sample after storage for a certain period of time (e.g., Days 1, 2, and 3) for a specific analyte when compared to the lab reading generated by the venous sample immediately upon collection

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy members of the community aged 18 years and over

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Roman Health Ventures Inc.: lead

Study Sites (1)

Roman Health Ventures Study Site

San Francisco, California, 94107, United States

RECRUITING

MeSH Terms

Conditions

Metabolic Diseases; Sexual Dysfunction, Physiological; Alopecia

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Genital Diseases; Urogenital Diseases; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Nitin Vaswani, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitin Vaswani, MD

CONTACT

7577263449; nitin.vaswani@ro.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 21, 2023
• Study Start: August 16, 2023
• Primary Completion (Estimated): July 31, 2033
• Study Completion (Estimated): August 15, 2033
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)