Tokyo, Oct. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063180) titled 'Nationwide Analysis of Radioligand Therapy Implementation in Japan: Trends and Barriers Using Claims Data and Questionnaire Survey' on Oct. 5.
Study Type:
Others,meta-analysis etc
Primary Sponsor:
Institute - National Cancer Center
Condition:
Condition - 1) Patients who received treatment with a radiopharmaceutical therapy agent listed on the National Health Insurance (NHI) drug price list in Japan.
Although [(131)I]I is approved in Japan for hyperthyroidism as well as thyroid cancer, this study will include only patients who received [(131)I]I for thyroid cancer.
2) Patients who initiated systemic therapy for a neuroendocrine neoplasm.
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The aims of this study are to clarify the implementation status of Radiopharmaceutical therapy (RPT) in Japan and its impact on treatment strategy in clinical practice.
Basic objectives2 - Others
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - For the Radioligand therapy component and the Neuroendocrine tumor Component, data will be extracted from the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) for patients who meet all of the following criteria. For the cross-sectional facility survey component, a questionnaire will be sent to medical institutions to collect information on the challenges they face in operating or implementing RPT.
1) RPT component
1. Patients with at least one claim during the study period (January 2017 to December 2025).
2. Patients who received treatment with an RPT agent listed on the National Health Insurance (NHI) drug price list in Japan.
Although 131I is approved in Japan for hyperthyroidism as well as thyroid cancer, this study will include only patients who received 131I for thyroid cancer.
RPT is listed on the NHI drug price list in Japan as of September 2025:
-Sodium iodide (131I)
-Strontium chloride (89Sr) (Metastron)
-90Y-ibritumomab tiuxetan (Zevalin)
-Radium chloride (223Ra) (Xofigo)
-177Lu-DOTATATE (Lutathera)
-131I-MIBG (3-iodobenzylguanidine 131I; Raiatt MIBG-I131)
If 177Lu-PSMA-617 (Pluvicto) is added to the NHI drug price list by December 2025, its inclusion in this study will be considered.
2) Neuroendocrine tumor component
1. Patients who had at least one medical encounter between January 2017 and December 2025.
2. Patients with a disease name code for a neuroendocrine neoplasm recorded in the NDB.
3. Patients who initiated systemic therapy for a neuroendocrine neoplasm.
3) Cross-sectional facility survey component.
1. Medical institutions participating in JON-HBP.
2. Institutions will be included regardless of whether they currently administer RPT.
Key exclusion criteria - Not applicable
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 12 Month 01 Day
Date of IRB - 2025 Year 12 Month 19 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072307
Disclaimer: Curated by HT Syndication.
