Clinical Research for Clinical Application of Cancer Multi-Gene Panel Testing with Ion Torrent Genexus Integrated Sequencer

JRCT ID: jRCTs072230003

Registered date:10/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Breast cancer, Pancreatobiliary cancer, Lung cancer, Head and neck cancer
• Date of first enrollment: 10/04/2023
• Target sample size: 14
• Study type: Interventional
• Intervention(s): Implementation of blood testing without covering health insurance

Outcome(s)

• Primary Outcome: Sensitivity and specificity of the FoundationOne CDx genome profile and the Ion Torrent Genexus Integrated Sequencer for gene mutation detection

Secondary Outcome

(1) Sensitivity and specificity of genetic mutation detection between Genexus-Oncomine Comprehensive Assay v3 and Genexus-Oncomine Precision Assay
(2) Time course of genetic mutation in blood after surgery
(3) Time course of nucleic acid concentration in blood after surgery
(4) Characteristics of genetic mutations according to organ and stage
(5) Differences of nucleic acid concentration in blood according to organ and stage
(6) Differences in genetic mutations between Genexus-OCAv3 and Genexus-OPA according to organ and stage
(7) Validation of quality control for cfTNA

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients diagnosed with breast, pancreatobiliary, lung, or head and neck cancer.
(2) Any age, gender, medical history, comorbidities, and stage of disease.
(3) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
(4) Having provided voluntary written consent for participation in this study.

Exclude criteria

(1) Patients with two or more cancers (multiple cancers) at the same time.
(2) Patients have active overlapping cancers (patients who have been recurrence-free for at least 5 years or after curative treatment for epithelial cancer may be enrolled).
(3) Patient has a serious complication
(4) Patient lacks the capacity to consent
(5) Patients who are deemed by the principal investigator and subinvestigators to be unable to participate in the study

Related Information

• Primary Sponsor: Naito Yoshiki