Tokyo, Feb. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060658) titled 'A Study on the Determination of Optimal Cutoff Values for Plasma Free Metanephrine and Normetanephrine in the Diagnosis of Pheochromocytoma Based on Real-World Clinical Practice' on Feb. 13.
Study Type:
Observational
Primary Sponsor:
Institute - University of Tsukuba
Condition:
Condition - pheochromocytoma and paraganglioma
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - This study aimed to establish real-world cutoff values for plasma-free fractionated metanephrines for the diagnosis of pheochromocytoma and paraganglioma using measurements obtained in routine clinical settings.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Eligible participants were adults aged 18 years or older who underwent measurement of pMN/pNMN using the 2-MET Plasma ELISA kit (SML) after its reimbursement from January 2019.
Key exclusion criteria - The following cases were excluded from the analysis based on medical record review:
(1) use of medications known to interfere with metanephrine measurements (e.g., antidepressants, atypical antipsychotics, sympathomimetic agents);
(2) ingestion of foods known to affect metanephrine measurements (e.g., caffeine-containing products, bananas, or vanilla) on the day of blood sampling;
(3) specimen collection performed during the treatment of acute illnesses or other clinical conditions likely to cause marked sympathetic activation;
(4) cases in which the presence or absence of PPGL could not be definitively determined due to insufficient pathological, imaging, or clinical follow-up data.
Target Size - 800
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2023 Year 03 Month 27 Day
Date of IRB - 2023 Year 04 Month 19 Day
Anticipated trial start date - 2023 Year 04 Month 19 Day
Last follow-up date - 2025 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069382
Disclaimer: Curated by HT Syndication.