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Biomarker analysis for high-risk stage I NSCLCs

A multi-institutional three-step retrospective study to explore novel molecular biomarkers that indicate high-risk of recurrence in surgically-resected pStage I non-squamous NSCLC patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1050220114
Enrollment
360
Registered
2022-11-04
Start date
2022-11-04
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-squamous NSCLC with pathological stage I disease surgically-resected non-squamous NSCLC

Interventions

None listed

Sponsors

Suda Kenichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Non-squamous NSCLC patients who received R0 resection Pure solid tumor at preoperative CT examination Patients who received lobectomy and mediastinal LN dissection Pathologically confirmed stage I NSCLC RNA sample is available (cohort 1) RNA sequence data is available (cohort 2) FFPE sample is available (cohort 3)

Exclusion criteria

Exclusion criteria: Patients who received neoadjuvant therapy Patients who died due to postoperative complication within 90 days after pulmonary resection Patients with lost follow up within 5 years In cohort3, patients who were enrolled in cohort 1 or cohort 2 will be excluded

Design outcomes

Primary

MeasureTime frame
Five-year disease free survivals in cohort 2 (Cohort 2 patients will be divided into high risk group vs. low risk group based on biomarker(s) identified in the analysis of cohort 1. Five-year DFS will be compared between high risk group and low risk group)

Secondary

MeasureTime frame
Five-year overall survivals in cohort 2 Five-year disease free and overall survivals in cohort 3 Five-year disease free and overall survivals in patients with EGFR mutation

Contacts

Public ContactKenichi Suda

Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine

ksuda@med.kindai.ac.jp+81-72-366-0221

Outcome results

None listed

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