Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Cisplatin based chemottherapy: adjuvant therapy for high risk patient

Study summary

For patients with lung cancer who have undergone tumor resection, early relapse significantly impacts survival. However, there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse. To address this clinical challenge, many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse. Despite these efforts, we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse. Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates.

In our preliminary analysis of previous study data, we observed that patients with a smaller reduction in circulating tumor cells (CTCs) within the first three days after surgery, followed by an increase on the third-day post-operation, are more likely to experience early relapse during regular monitoring. This pattern may be indicative of minimal residual disease. By combining trends in circulating tumor cell variations with pathologic characteristics, we aim to select patients for adjuvant therapy who are at high risk of developing early relapse.

The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases.

Eligibility

Primary outcome measure(s)

• Accuracy of proposed relapse prediction model — follow up in 3 month-interval
  1. Utilized the enrolled patients to testify proposed relapse prediction model 2. Calculated Positive prediction rate, Negative prediction rate, accuracy 3. Goal: high positive prediction rate, lower negative prediction rate, high accuracy
• early relapse rate — follow up in 3 month-interval
  1. adjuvant therapy based on proposed relapse prediction model * calculate the early relapse rate (relapse within 3 years) 2. utilized historical cohort as historical control (cohort that utilized to establish proposed relapse prediction model * adjuvant therapy based on TNM stage * calculate the early relapse rate (relapse within 3 years) * follow up Chest CT/ CTC in 3-month interval

Trial sites (1)

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