Tokyo, Nov. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059863) titled 'Development to localize endocrine tumors using cell-free DNA obtained from tumor venous blood sampling' on Nov. 23.
Study Type:
Observational
Primary Sponsor:
Institute - Nagasaki University Hospital
Condition:
Condition - Primary aldsteronism,or Cushing disease
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - In venous sampling for diagnosing the localization of endocrine tumors including primary aldosteronism and Cushing's disease, we mesure circulating tumor DNA (cell-free DNA: cfDNA) in addition to measuring hormone levels to improve the accuracy of tumor localization.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients with an endocrinological diagnosis of primary aldosteronism or Cushing's disease who will undergo AVS or IPS/CS sampling for the purpose of localization.
2. Patients aged 18 years or older.
3. Patients who have received a thorough explanation of participation in this study and have provided their voluntary written consent with a full understanding.
Key exclusion criteria - 1. Pregnant or lactating patients
2. Patients in whom it is difficult to collect an additional 5 ml of blood from each of the left and right (or central/peripheral) venous sampling sites
3. Patients who are otherwise deemed inappropriate for this study by the principal investigator.
Target Size - 102
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 11 Month 06 Day
Date of IRB - 2025 Year 11 Month 06 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2031 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068456
Disclaimer: Curated by HT Syndication.