MRD DETECTION AND LONGITUDINAL MONITORING OF MOLECULAR RECURRENCE USING GUARDANT REVEAL ASSAY IN LUNG CANCER PATIENTS WHO RECEIVE CURATIVE-INTENT LOCAL TREATMENTS

JRCT ID: jRCT1050240085

Registered date:05/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 05/07/2024
• Target sample size: 40
• Study type: Observational

Outcome(s)

• Primary Outcome: To examine the minimal residual disease (MRD) detection rate, using the Guardant Reveal Assay, in NSCLC patients who receive curative-intent local treatments.

Secondary Outcome

To examine duration between molecular recurrence, detected by the Guardant Reveal Assay, and clinical recurrence, detected by radiological examination(s) including CT scan, PET-CT, or brain MRI scan, in NSCLC patients who receive curative-intent local treatments.
To examine correlation between MRD detection, using the Guardant Reveal Assay, and other potential prognostic biomarkers including tumor size, lymph node status, histological grade, and vascular invasion for patients who receive surgical resection.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Include criteria: Patients who have undergone radical resection for NSCLC (including those who have undergone neoadjuvant chemotherapy) and whose pathological stage is found to be II or III. Patients whose pathological stage is II or III and who are being followed up at our department as outpatients within the past 2 years since surgery. Or patients who have undergone local therapy (surgery, radiation therapy, radiochemotherapy, ablation, etc.) with curative intent for oligorecurrence (two or fewer recurrent lesions) within the past 2 years.
• Exclude criteria: Patients diagnosed with large cell neuroendocrine carcinoma (LCNEC). Patients receiving adjuvant osimertinib therapy (patients receiving single-agent immune checkpoint inhibitors can be enrolled).

Related Information

• Primary Sponsor: Kenichi Suda
• Secondary Sponsor: Guardant Health Inc.