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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-90
SponsorChang Gung Memorial Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who presented with resectable disease ( Clinical stage 1a to 3a)

Patients who received tumor resection

Disqualifiers

Pathologic stage greater than stage 3b or 4

Pathologic stage less than stage 1a1

Could not complete treatment course

Could not receive blood sampling for CTC (circulating tumor cell) or regular surveillance

Trial design

Design model

Single group

Treatments tested in this trial

  • Cisplatin based chemottherapy

    Drug

    adjuvant therapy for high risk patient

Treatment groups

358 Participants
are divided into 1 treatment group
Group A: Patient at risk for disease relapse after surgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Accuracy of proposed relapse prediction model

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

Time frame
follow up in 3 month-interval
2

early relapse rate

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

Time frame
follow up in 3 month-interval

Secondary outcomes

1

Overall surveival

Goal: difference of overall survival among patients with relapse risk 1. treatment based on proposed relapse prediction model 2. calculate the overall survival 3. utilized historical cohort as historical control ( cohort that utilized to establish proposed relapse prediction model * treatment based on TNM stage * calculate the overall survival rate

Time frame
follow up in 3 month-interval

Other outcomes

Sponsors and contacts

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Chang Gung Memorial Hospital

Lead sponsor

National Science and Technology Council

Collaborator