Clinical 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

Name
202202172B0
Description
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.
Trial arms
Trial start
2023-08-01
Estimated PCD
2028-07-31
Trial end
2028-07-31
Status
Recruiting
Treatment
Cisplatin based chemottherapy
adjuvant therapy for high risk patient
Arms:
Patient at risk for disease relapse after surgery
Size
358
Primary endpoint
Accuracy of proposed relapse prediction model
follow up in 3 month-interval
early relapse rate
follow up in 3 month-interval
Eligibility criteria
Inclusion Criteria: 1. Patients who presented with resectable disease ( Clinical stage 1a to 3a) 2. Patients who received tumor resection Exclusion Criteria: 1. Pathologic stage greater than stage 3b or 4 2. Pathologic stage less than stage 1a1 3. Could not complete treatment course 4. Could not receive blood sampling for CTC (circulating tumor cell) or regular surveillance
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 358, 'type': 'ESTIMATED'}}
Updated at
2024-02-16

1 organization

1 product

2 indications

Product
Cisplatin
Indication
lung cancer