Clinical Significance of Circulating Tumor Cell in Non Small Cell Lung Cancer

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT03724500
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

From literature review, circulating tumor cell was demonstrated its possible role in disease relapse. It was rare nit could be identified in all lung cancer patients. In addition, circulating tumor cell usual aggregate to form circulating tumor micro-emboli and caused distant metastases. Therefore, circulating tumor cell could play a role in detect disease relapse and appropriate treatment could be given more earlier and further prolong patients' survival. However, the detail clinical significance of circulating tumor still remain unknown. The aim of this study was evaluate the clinical significance, including present timing, numbers, and correlation to disease relapse, of circulating tumor cell in lung cancer patients. Investigators want to clarify the clinical significance between circulating tumor cell and clinical presentation of lung cancer in order to establish new prediction model and improve lung cancer patients' survival.

Detailed Description

Lung cancer was a major cause of cancer-related death worldwide. According to statistical data from Ministry of Health and Welfare, the incidence of lung cancer related death was 25.5 per 100,000 population. According to NCCN guideline, the standard treatment for patients with resectable disease is anatomic resection and mediastinal lymph node dissection. The current prognostic system, TNM system, was based of patho-histologic characteristics and this system provide the most important information about disease-free and overall survival for corresponding disease severity. According to investigators previous studies, investigators've identified risk factors for all lung cancer patients with resectable disease and poor prognostic factors in different TNM stage. Investigators could utilized factors that designed for all patients as an initial survey and further subgroup patients into high or low risk for relapse in subsequent stratification that utilized grading system in different TMN stage. If investigators could identified high risk patients, more aggressive treatment and follow up program may decreased risk of disease relapse and prolong patient survival.

From literature review, circulating tumor cell was demonstrated its possible role in disease relapse. It was rare nit could be identified in all lung cancer patients. In addition, circulating tumor cell usual aggregate to form circulating tumor micro-emboli and caused distant metastases. Therefore, circulating tumor cell could play a role in detect disease relapse and appropriate treatment could be given more earlier and further prolong patients' survival. However, the detail clinical significance of circulating tumor still remain unknown. The aim of this study was evaluate the clinical significance, including present timing, numbers, and correlation to disease relapse, of circulating tumor cell in lung cancer patients. Investigators want to clarify the clinical significance between circulating tumor cell and clinical presentation of lung cancer in order to establish new prediction model and improve lung cancer patients' survival.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Status Verified: 2023-09
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Non-small cell lung cancer patients with stage I to III

2. Patients with resectable suspicious pulmonary malignant lesion

   1. no pre-operation diagnosis ( patients refused biopsy or difficult for biopsy)
   2. image survey showed clinical stage I to III

Exclusion Criteria

1. Final pathology coexisted with small cell lung cancer component
2. Patients who presented as stage IIIb or IV.
3. Not received curative intended surgery due to multi-comorbidities.
4. Patients who presented in tumor seeding or positive resection in the final pathology
5. Patients who received neoadjuvant therapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation trend of circulating tumor cell counts	1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.need complete 5-years surveillance (disease status confirmation)	Relationship between variation trend of circulating tumor cells and disease relapse in patients with a suspicious pulmonary lesion after tumor resection

Secondary Outcome Measures

Name	Time	Method
Malignancy prediction capacity of circulating tumor cell counts	Pre-operation circulating tumor cells ( sampled before operation at operation day)	Relationship between pre-operation circulating tumor cell counts and malignancy

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan