Monitoring Recurrence of Individual tumor by serial Observation of Known gene Alterations

JRCT ID: jRCT1020190017

Registered date:24/01/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pan-cancer (approximately 20 types of origins)
• Date of first enrollment: 01/07/2019
• Target sample size: 200
• Countries of recruitment: Republic of Korea,Japan
• Study type: Observational
• Intervention(s): N/A

Outcome(s)

• Primary Outcome: Progression-free survival

Secondary Outcome

>Proportion of cases whose ctDNA changes according to tumor burden
>Proportion of cases whose ctDNA changes while tumor burden changes

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 85age old
• Gender: Both

Include criteria

>Diagnosis of malignancy. Histologic diagnosis is preferred but not mandatory.
>Intention to treat for volume reduction or growth suppression of the tumor. Cases receive secondary treatment are eligible. Cases with nodes or organ metastasis are accepted.
>Estimated life expectancy is longer than 180 days.
>Stages estimated having approximately 30% recurrence rate.
>Pre-treatment blood sample is available.

Exclude criteria

>Treatment has initiated without pre-treatment blood sample.
>Pregnancy.
>Periodical survey is difficult due to location or financial reasons.
>Any other ineligible reasons.

Related Information

• Primary Sponsor: Nishizuka Satoshi
• Source(s) of Monetary Support: Taiho Pharmaceuticals, Co. Ltd.,Nippon Boehringer Ingelheim Co ., Ltd.,Geninus,Array Jet