Validation of the Clinical Value of Interstitial Fluid Biomarkers in Skin

JRCT ID: jRCT1032230545

Registered date:09/01/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Thyroid Diseases, Cardiovascular Diseases, Respiratory Diseases, Healthy Adults
• Date of first enrollment: 09/01/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Blisters formed on the bilateral forearms or thighs using the Negative Pressure Cutaneous Suction System [NP-4] are punctured with a syringe and needle to collect the fluid contents (cutaneousinterstitial fluid) and the BMs measured.

Outcome(s)

• Primary Outcome: The difference between the skin interstitial fluid BMs collected from patients with each disease with the skin interstitial fluid BMs collected from healthy adults.
• Secondary Outcome: The difference between skin interstitial fluid BM measurements and blood BM measurements

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

(1) Patients who are outpatients or inpatients with blood biomarkers (BM) above or below the threshold level established for each disease, or healthy adults with normal BMs.
(2) Patients who are at least 18 years old and less than 70 years old at the time of consent.
(3) (Healthy adult group only) Body Mass Index between 18.5 and 25.0
(4) Patients who can obtain document consent with their own will before any study related procedure

Exclude criteria

(1) Those who are unable to undergo blood tests.
(2) Persons with obvious skin abnormalities (abnormal pigmentation, swelling, wounds, etc.) at the site of interstitial fluid collection (bilateral forearms)
(3) Patients who have received an injectable medication or vaccination within 1 week.
(4) (Healthy adult group only) Those who are allergic to inhaled allergens (pollen, house dust, etc.)
(5) (Healthy adult group only) Those with allergies to food, drugs, metals, etc., and have confirmed exposure to the relevant allergens within 1 week.
(6) (Healthy adult group only) Those who have suffered a traumatic injury or received invasive treatment within 1 week.
(7) (Healthy adult group only) Persons who have contracted an infectious disease within 3 weeks
(8) Persons with hypersensitivity to raw materials (aluminum alloy and polypropylene) used in the research equipment.
(9) Other persons who are judged to be ineligible by the principal investigators or research assistants.

Related Information

• Primary Sponsor: Nakamura Kenjiro