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

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03724500
Collaborator
(none)
65
Enrollment
1
Location
82.9
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    65 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Significance of Circulating Tumor Cell in Non Small Cell Lung Cancer
    Actual Study Start Date :
    Feb 1, 2017
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

    2. Patients with resectable suspicious pulmonary malignant lesion

    3. no pre-operation diagnosis ( patients refused biopsy or difficult for biopsy)

    4. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chang Gung Memorial Hospital Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

    • Principal Investigator: Chia-Hsun Hsieh, MD, Chang Gung Memorial Hospital
    • Principal Investigator: Yi-Cheng Wu, MD, Chang Gung Memorial Hospital
    • Principal Investigator: Cheng-Ta Yang, MD, Chang Gung Memorial Hospital
    • Principal Investigator: JUI-YING Fu, MD, Chang Gung Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT03724500
    Other Study ID Numbers:
    • CGMH-IRB-104-8753B
    First Posted:
    Oct 30, 2018
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chang Gung Memorial Hospital
    Non small cell lung cancer
    Circulating tumor cell
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Neoplastic Cells, Circulating

    Study Results

    No Results Posted as of Mar 29, 2022