The study is positioned as the pivotal trial behind a planned manufacturing and marketing approval application to Japan's Ministry of Health, Labour and Welfare, with Craif targeting a 2026 medical device approval application. No trial results are being reported.
Craif Inc. (head office: Bunkyo City, Tokyo; CEO: Ryuichi Onose) has started a multicenter clinical trial of a program medical device that is intended to aid the diagnosis of pancreatic cancer, based on an AI algorithm applied to microRNA and other markers in urine.
The trial is positioned as a pivotal trial to obtain the main clinical data, and it is being conducted for the purpose of an application for manufacturing and marketing approval to Japan's Ministry of Health, Labour and Welfare. Craif is aiming to file a medical device approval application in 2026.
Starting a trial is not an approval and not a result. The device is investigational, no performance data is being reported here, and nothing in this release should be read as a claim about how the device performs.
What the device is intended to do
The device calculates a score from the expression levels of microRNA and other markers in urine, and returns a positive or negative determination. That determination is used as an aid to diagnosis of pancreatic cancer. It does not make a diagnosis, which remains a physician's judgment.
The intended use is comparable to that of existing tumor markers and abdominal ultrasound: in a patient who has clinical symptoms of pancreatic cancer or risk factors for it, and in whom pancreatic cancer is suspected, the result is one input into deciding whether to proceed to more detailed testing.
Who the trial device is intended for
Use is planned in patients in whom pancreatic cancer is suspected and in high-risk patients.
High risk is defined for the purposes of this trial as having one or more of the following: type 2 diabetes, chronic pancreatitis, a family history of pancreatic cancer, intraductal papillary mucinous neoplasm, pancreatic cyst, or pancreatic duct dilatation.
Why pancreatic cancer is hard to catch early
Pancreatic cancer has a poor prognosis and is very difficult to detect early. Deaths from it are rising year on year, and in Japan in 2023 it passed stomach cancer to rank third (Ministry of Health, Labour and Welfare, Vital Statistics 2023).
The five-year relative survival rate is around 10 percent, conspicuously low among malignancies, and markedly lower at advanced stages: 6.8 percent at stage III and 1.4 percent at stage IV (National Cancer Center Japan, Cancer Registry and Statistics, five-year survival for 2013 to 2014).
Early-stage disease produces few symptoms and few that are specific. Tumor markers such as CA19-9 often show no change. No useful method for early detection has yet been established.
Why urinary microRNA
Craif is using AI to identify microRNA profiles and related patterns that are characteristic of pancreatic cancer, including at early stages, and is developing a program medical device that uses the analysis of those expression profiles to aid diagnosis.
Among cancer-related biomarkers, microRNA is regarded as well suited to early detection: tumor cells and the cells around them are thought to begin secreting microRNA in patterns that differ from normal, by way of exosomes, while the tumor is still small.
Comment from a physician participating in the trial
Koji Yoshida, Professor in the Department of Gastroenterology at Kawasaki Medical School, said: "Pancreatic cancer progresses quickly, so early detection matters for treatment outcomes. The sensitivity of tumor markers is not sufficient and detecting early-stage cancer is difficult. Being able to pick up an early signal from microRNA using urine, which is non-invasive, is a major step forward."
Trial outline
- Trial name: Study of pancreatic cancer diagnostic performance using a machine learning model with urinary biomarkers
- Target number of participants: 800
- Expected completion: December 2025
- UMIN trial ID: UMIN000053882
- Registry record: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000061507
Multicenter here means a trial conducted jointly at multiple institutions under a single protocol, which allows differences between institutions to be taken into account in the evaluation.
Regulatory status
The trial is being conducted for the purpose of an application for manufacturing and marketing approval to Japan's Ministry of Health, Labour and Welfare, and Craif is aiming to file a medical device approval application in 2026.
The device is investigational. It has not been approved or cleared in Japan or in any other country, it is not available for sale or for clinical use, and the start of this trial confers no regulatory status.
Company details
- Company: Craif Inc.
- Representative: Ryuichi Onose, Representative Director
- Founded: May 2018
- Business: research and development of next-generation testing aimed at the early detection of disease, centered on cancer, and at personalized medicine; provision of the miSignal series of next-generation cancer risk tests
- Head office: ITP Hongo Office 5F, 2-25-7 Yushima, Bunkyo City, Tokyo
URL: https://craif.com/
