Development of domestic multiplex gene panel test for cancer personalized medicine

JRCT ID: jRCT1062200037

Registered date:21/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Solid cancers
• Date of first enrollment: 21/12/2020
• Target sample size: 250
• Study type: Interventional
• Intervention(s): TSO500 is an unapproved diagnostic test, and the test results will be potentially used for the treatment decision making. Therefore, it is treated as "research with intervention".

Outcome(s)

• Primary Outcome: The detection rate of actionable genetic alterations

Secondary Outcome

The successful rate of sequencing
The treatment rate of the actionable drugs
The concordance rate of the results between panels

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age : 16-year-old or more.
2) Performance Status (ECOG criteria) : 0 or 1
3) Histologically proven solid cancers available for the tissues with enough tumor contents.
4) Solid cancers (including cancer of unknown primary ) with unresectable and relapse disease, that 1) do not have standard treatment, 2) have completed or are expected to complete standard treatment.
5) Written informed consent

• Exclude criteria: Patients who refuse to participate in the study

Related Information

• Primary Sponsor: Ennishi Daisuke