Biomarker analysis for high-risk stage I NSCLCs

JRCT ID: jRCT1050220114

Registered date:04/11/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: non-squamous NSCLC with pathological stage I disease
• Date of first enrollment: 04/11/2022
• Target sample size: 360
• Study type: Observational

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

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

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Suda Kenichi
• Source(s) of Monetary Support: AstraZeneca