Craif (Location: Bunkyo-ku, Tokyo, CEO: Ryuichi Onose, hereinafter referred to as “Craif”) has entered into a joint study agreement with National Cancer Center Japan (Location: Chuo-ku Tokyo, President: Hitoshi Nakagama, hereinafter referred to as “NCC”). With the conclusion of this agreement, Craif and National Cancer Center Hospital East (Location: Kashiwa-shi Chiba, Director: Atsushi Ohtsu) will begin multicenter joint study to investigate “the effectiveness of urinary miRNA analysis in diagnosis and radiotherapy for squamous cell carcinoma of the head and neck,” and “the effectiveness of urinary miRNA analysis in preoperative radiotherapy for rectal cancer.”

■Outline of the two studies
1. Multicenter Joint Study to Investigate the Effectiveness of Urinary miRNA Analysis in Diagnosis and Radiotherapy for Squamous Cell Carcinoma of the Head and Neck
Unlike surgical procedures for head and neck cancer, radiotherapy can preserve the function and structure of the affected part. On the other hand, early detection of recurrence after the treatment is important to consider the necessity for speedy salvage surgery. Although it is technically feasible to perform local biopsy to confirm the response after radiotherapy, it has been a problem since it is highly invasive and might lead to prolonged acute adverse events. Urinary miRNA measurement is non-invasive and said to be effective for diagnosing and predicting recurrence of various cancers by examining its profile. Through this study, Craif and NCC will analyze the correlation between the profile of urinary miRNA and the response rate of radiotherapy and prognosis to examine whether we can predict the diagnosis and response and prognosis towards the treatment.

2. Multicenter Joint Study to Investigate the Effectiveness of Urinary miRNA Analysis in Preoperative Radiotherapy for Rectal Cancer
Recently, radiotherapy is widely used in cancer treatment. The greatest advantage of radiotherapy is that it enables curative treatment while preserving organs. Preoperative chemoradiotherapy is one of the standard treatments for locally advanced rectal cancer. Although preoperative chemoradiotherapy is usually considered to be a preoperative treatment followed by a surgery, it is said that preoperative chemoradiotherapy itself can achieve a pathological complete response rate of around 20%. Furthermore, in order to increase the patient QOL through organ preservation, the option of avoiding surgery and continuing follow-up has been considered recently. However, since there are cases of recurrence during follow-up, the development of a biomarker that can predict the disease condition is desired. In this study, Craif and NCC will analyze urinary miRNA of rectal cancer before and after the preoperative radiation therapy, to see if it can predict the response and recurrence towards the treatment.