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A Prospective Observational Study on the Efficacy of Multiplex Genetic Analysis by Means of a Next-Generation Sequencer Using Cell-Free DNA

A Prospective Observational Study on the Efficacy of Multiplex Genetic Analysis by Means of a Next-Generation Sequencer Using Cell-Free DNA - LC-SCRUM-Liquid

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000030496
Enrollment
2000
Registered
2017-12-25
Start date
2017-12-25
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Non-small cell lung cancer

Interventions

None listed

Sponsors

National Cancer Center Hospital East
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 20 years old or above 2. Pathologically confirmed non-small cell lung cancer (regardless of histology or cytology) 3. Clinical stage III, stage IV or postsurgical relapse at the time of registration. 4. The disease is inoperable and ineligible for radical radiation therapy, and chemotherapy is planned. 5. The subject is chemotherapy naive or had a history of chemotherapy of no more than 2 regimens. 6. Enrollment in a prospective observational study to clarify the clinicopathological and molecular biological features of lung cancer with low-frequency genetic changes, such as the RET fusion gene, in non-small cell lung cancer. 7. The patient who can provide blood sample within 4 weeks of tumor sample collection. The patient is going to be excluded if prescribed blood sample cannot be collected. 8. With written informed consent.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Concordance of Guardant360 data for ctDNA and NGS data for tumor samples by Oncomine Comprehensive Assay (OCA)

Secondary

MeasureTime frame
1.The percentage of patients observed to have alterations to the 7 driver genes (EGFR, ALK, ROS1, BRAF, MET, RET, ERBB2). 2.Clinical efficacy (response rate, time to treatment failure, overall survival period) of molecular-targeted therapy in patients in whom genetic alterations are detected by Guardant360. 3.Time course of molecular profiling change which are related with drug resistance.

Countries

Japan

Contacts

Public ContactYuko Usui, Shigeki Umemura, Koichi Goto

National Cancer Center Hospital East Department of Thoracic Oncology

sumemura@east.ncc.go.jp04-7133-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026