Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Relapse/Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin based chemottherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient at risk for disease relapse after surgery
- description
- 1. we utilized a relapse prediction model that combined perioperative variation trends of circulating tumor cells and pathologic characteristics that were collated with relapse 1. circulating tumor cell variation trend: difference between the CTC count on post-operation day 3 and day 1; difference between the CTC count on post-operation day 3 and post-operation 2. pathologic staging 0-1a/ 1b-4 2. patient with high relapse for relapse * Adjuvant was recommended as NCCN guidelines recommended
- interventionNames
- Drug: Cisplatin based chemottherapy
Primary outcomes (2)
- measure
- Accuracy of proposed relapse prediction model
- timeFrame
- follow up in 3 month-interval
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (35)
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