Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial
NCT ID: NCT06262386
Last Updated: 2024-02-16
Study Results
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Basic Information
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RECRUITING
NA
358 participants
INTERVENTIONAL
2023-08-01
2028-07-31
Brief Summary
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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.
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Detailed Description
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Survival studies have predominantly focused on the pathologic TNM stage, which aggregates different disease presentations with similar survival outcomes. However, the heterogeneity inherent in pathology may help in identifying patients prone to relapse. From a tumor biology perspective, tumor cells may detach from surrounding tissues, becoming more invasive and entering the bloodstream. Circulating tumor cells (CTCs) have been recognized early in cancer stages and are correlated with treatment response, tumor genetic alterations, and survival. Research has combined CT tumor size and CTCs in a malignancy prediction model for suspicious pulmonary lesions, highlighting that CTCs can rebound in patients experiencing early relapse, indicating occult metastases or minimal residual disease.
Systemic adjuvant therapy is considered the best approach to minimize disease relapse in resectable lung cancer patients. Although many studies have sought to identify patients at risk of relapse to improve survival, the presence of intrapulmonary (N1) or mediastinal (N2) lymph node invasion significantly affects survival in non-small cell lung cancer patients. Even tumors smaller than 1 cm carry a risk of lymph node metastases, with respective risks for cT1a, cT1b, and cT1c tumors reported as 3.8%, 16.3%, and 19.6%. Therefore, patients with tumors larger than 1 cm are recommended adjuvant therapy due to the high risk of lymph node involvement. Adjuvant chemotherapy is advised for patients with stages 1b to 3a, showing a 5.4% survival benefit by the fifth postoperative year, although this benefit diminishes in subsequent years. This could be due to adjuvant therapy being administered based on the pathologic stage rather than the likelihood of relapse. Tumor heterogeneity might also influence the response to different therapeutic regimens. Molecular profiling of tumors has identified mutations predicting responses to targeted therapies and elucidated drug resistance mechanisms, offering more precise treatments and improving survival. Targeted and immune therapies have shown improved survival in specific tumor subgroups.
This study aims to utilize trends in CTC variations as a screening tool to identify patients at risk of relapse and prescribe adjuvant therapy to evaluate the therapeutic efficacy and survival impact of CTCs.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patient at risk for disease relapse after surgery
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
Cisplatin based chemottherapy
adjuvant therapy for high risk patient
Interventions
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Cisplatin based chemottherapy
adjuvant therapy for high risk patient
Eligibility Criteria
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Inclusion Criteria
2. Patients who received tumor resection
Exclusion Criteria
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
20 Years
90 Years
ALL
No
Sponsors
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National Science and Technology Council
FED
Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Ching-Yang Wu
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Ching-Yang Wu
Taoyuan, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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202202172B0
Identifier Type: -
Identifier Source: org_study_id
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