Tokyo, May 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061732) titled 'Detection characteristics of ALK fusion genes in surgically resected lung cancer specimens using immunohistochemistry and multigene PCR panel' on May 29.
Study Type:
Observational
Primary Sponsor:
Institute - Tohoku University Hospital
Condition:
Condition - non-small cell lung cancer
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - This study aims to retrospectively evaluate the detection characteristics of ALK fusion genes based on test results obtained by immunohistochemistry (IHC) and the AmoyDx assay.
Basic objectives2 - Others
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - (1) Histologically diagnosed as non-small cell lung cancer using surgically resected specimens.
(2) Meeting one of the following conditions:
(a) Surgery was performed between January 2018 and December 2021, and ALK testing by IHC was conducted using surgical specimens.
(b) Surgery was performed between January 2022 and December 2025, and ALK testing by the AmoyDx assay was conducted using surgical specimens.
Key exclusion criteria - (1) Cases in which the study participant (or a legally authorized representative) expressed a wish not to participate in the study.
(2) Cases unable to undergo additional IHC testing because of insufficient remaining specimen material.
Target Size - 1004
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 27 Day
Date of IRB - 2026 Year 05 Month 27 Day
Anticipated trial start date - 2026 Year 06 Month 15 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070617
Disclaimer: Curated by HT Syndication.
