RecruitingNot ApplicableNCT06262386

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

Utilizing Perioperative Variation Trends of Circulating Tumor Cells and Tumor Pathological Characteristics as a Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial


Sponsor

Chang Gung Memorial Hospital

Enrollment

358 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is building and testing a model that combines multiple types of data — including circulating tumor cells in the blood and imaging — to predict whether non-small cell lung cancer (NSCLC) will come back after surgery. This is an observational study, meaning participants receive standard care. **You may be eligible if...** - You have non-small cell lung cancer that was operable at diagnosis (clinical stage 1A to 3A) - You have already had surgery to remove the tumor **You may NOT be eligible if...** - Your final surgical stage was greater than 3B or Stage 4 (too advanced) - Your final surgical stage was less than 1A1 (very early) - You were unable to complete your planned treatment course - You cannot provide blood samples for circulating tumor cell testing or undergo regular surveillance Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCisplatin based chemottherapy

adjuvant therapy for high risk patient


Locations(1)

Ching-Yang Wu

Taoyuan City, Taiwan

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NCT06262386


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