CHOICE Study

Overview

The CHOICE Study is a prospective clinical study to identify the clinical characteristics of patients with advanced cholangiocarcinoma who harbor the fibroblast growth factor receptor (FGFR) 2 rearrangement.
This study will be focusing on patients from Asian countries, to have a better understanding of the distribution and frequency of patients with FGFR2 fusion gene-positive cholangiocarcinoma in Asia, which has not been clarified yet. Another focus of this study is the use of two gene testing methods; FISH and NGS, to identify the FGFR2 fusion gene in this specific population.

Progress

The patient registration period for this study has been ended. Data analysis is currently underway. (As of May 2024)

Background

Globally, cholangiocarcinoma is classified as a rare cancer, but its incidence rates exhibit geographical variation, with much higher incidence in Asia compared to the western countries. It is a highly aggressive cancer with poor prognosis due to limited treatment options. However, several new target molecules have recently been discovered, giving us a clue for improving therapeutic approaches for this cancer. One molecule that has gained attention is the FGFR2 fusion gene, with several molecular targeted agents under investigation worldwide. Despite the high frequently of cholangiocarcinoma reported in the Asia-Pacific region, clinical and biomarker data are lacking from these areas, which results in the drug development to be centered outside of Asia-Pacific, such as Europe, the United States, and Japan. Therefore, more studies are needed to elucidate the molecular background of cholangiocarcinoma patients from the Asian countries.
This study is conducted as an Asian multicenter prospective study to comprehensively investigate FGFR2 fusion genes and other genomic alterations in patients with metastatic and/or recurrent cholangiocarcinoma. The study name comes from: “Molecular detection and clinicopathological characteristics of advanced/recurrent CHOlangiocarcinoma harboring FGFR2 rearrangements In Asian CountriEs: CHOICE study,” and is as part of the NCCH’s project for promoting rare cancer research and development and genomic medicine in Asia, “Marker Assisted Selective ThErapy in Rare cancers: Knowledge database Establishing registry, Asia; MASTER KEY Asia” (Note 3).
MASTER KEY Asia, a global study in Asia, was expanded from the “MASTER KEY Project” (Note 4) launched in 2017 in Japan for driving research and development on rare cancers and for promoting genomic medicine, and has become a successful collaboration between industry and academia. MASTER KEY Asia has two major purposes: (1) to comprehensively collect molecular information on patients with rare cancers along with the treatment and prognosis data to establish a large-scale database serving as basic study data and (2) to conduct multiple investigator- or industry-initiated trials in patients with rare cancers or a specific biomarker irrespective of cancer type.
CHOICE study will collect data on patients with cholangiocarcinoma from Asia, adding on to the MASTER KEY Project (Japan), to build an all-Asia database for cholangiocarcinoma patients and contributing to the elucidation of its pathogenesis. We believe that the study will give hope for improving treatment of patients suffering from this cancer not only for the Asian region but for patients worldwide.

ClinicalTrials.gov registration number

NCT05217407

Origin of the logomark & mascot-character

The CHOICE-study’s logo was designed based on the MASTER KEY Asia’s logo, as both studies share the same platform while being conducted under the ATLAS project.
The shape of the key is designed with an arrow representing “choice” at the right end and a blank space surrounding it which represents the letter “C”.
The coloring is based on “kelly green,” the symbolic color of biliary tract cancer.

“Billy-kun” is a cheerful mascot character of the CHOICE study. He is an active boy born on Master Key Island, along with “Master-kun” and “Key-chan”, the lovable mascot characters of the MASTER KEY Asia study.
He continues his various adventures　day in day out, with a compass in his hand, seeking the truth in the treatment of cholangiocarcinoma.