Measurement of Thyroid disease related markers in small amount of specimen

JRCT ID: jRCTs032210630

Registered date:25/02/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Thyroid disease
• Date of first enrollment: 12/07/2022
• Target sample size: 55
• Study type: Interventional
• Intervention(s): In addition to regular medical care, the participants are collected their blood with an unapproved self-blood collection apparatus.

Outcome(s)

• Primary Outcome: Obtain patient samples with thyroid disease derived from venous blood and capillary blood taken by microneedle self-sampling device. The number of samples are equal to or greater than 50, including 7 patients who have high TSH value. Comparison of slope and correlation by Passing-Bablok method for both TSH and FreeT4.
• Secondary Outcome: Use same sample set used for TSH and FreeT4 measurements to measure the biomarkers for monitoring the side effect by thyroid disease treatment such as ALT, AST, Total bilirubin, and Creatinine.

Key inclusion & exclusion criteria

• Age minimum: >= 21age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Those whose age is 21 or older. (Helthy volunteers, patients)
2. Those who come to Ito Hospital. (Patients)
3. Those who collected blood on the day of obtaining consent (Patients)
4. Those who can agree informed consent by their own intention. (Healthy volunteers, patients)
5. P.I. or contributor decide the sample as appropriate for this research. (patients)

Exclude criteria

1. Those who come to Ito Hospital at first time. (Patients)
2. Those who have injured skin (broken, swollen, rash) on their upper arms. (Healthy volunteers, patients)
3. Those who have allergic to stainless steel. (Healthy volunteers, patients)
4. P.I. or contributor decide the sample as inappropriate for this research. (Healthy volunteers, patients)

Related Information

• Primary Sponsor: Yoshimura Hiroshi
• Source(s) of Monetary Support: Abbott Japan LLC