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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs072230003

Enrollment

Registered

2023-04-10

Start date

2023-04-10

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, Pancreatobiliary cancer, Lung cancer, Head and neck cancer Cancer, Breast cancer, Pancreatobiliary cancer, Lung cancer, Head and Neck cancer

Interventions

Implementation of blood testing without covering health insurance

Blood testing

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of the FoundationOne CDx genome profile and the Ion Torrent Genexus Integrated Sequencer for gene mutation detection	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Contacts

Public ContactKenji Fujiyoshi

Kurume University Hospital

fujiyoshi_kenji@med.kurume-u.ac.jp+81-942-31-7566

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026