Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059606) titled 'Epidemiological study of epNEC and LCNEC-L patients in Japan using the MASTER KEY Registry' on Oct. 31.
Study Type:
Observational
Primary Sponsor:
Institute - Nippon Boehringer Ingelheim Co., Ltd.
Condition:
Condition - extra-pulmonary neuroendocrine carcinoma (epNEC) and large cell neuroendocrine carcinoma of the lung (LCNEC-L)
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - Among patients with epNEC and LCNEC-L in the MASTER KEY Registry Database, to describe:
A) Patient demographics, clinical characteristics and biomarkers
B) Treatment status at each line of pharmacotherapy (LOP)
C) Treatment outcomes by each LOP and each treatment regimen
- Real-world objective response rate [rwORR]
- Real-world disease control rate [rwDCR]
- Real-world overall survival [rwOS]
- Real-world progression free survival [rwPFS]
- Real-world time to next treatment [rwTTNT]
Basic objectives2 - Others
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Patients who gave a written consent to the MASTER KEY Registry (NCCH1612) and were enrolled in it
2) Clinical diagnosis of epNEC or LCNEC-L
3) Patients with any records of pharmacotherapy
Key exclusion criteria - None.
Target Size - 99
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 02 Month 14 Day
Date of IRB - 2025 Year 08 Month 29 Day
Anticipated trial start date - 2025 Year 08 Month 29 Day
Last follow-up date - 2025 Year 08 Month 29 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063960
Disclaimer: Curated by HT Syndication.
