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

September 22, 2023 updated by: Chang Gung Memorial Hospital
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 Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with a resectable malignant or suspicious malignant pulmonary lesion

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation trend of circulating tumor cell counts
Time Frame: 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
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Malignancy prediction capacity of circulating tumor cell counts
Time Frame: Pre-operation circulating tumor cells ( sampled before operation at operation day)
Relationship between pre-operation circulating tumor cell counts and malignancy
Pre-operation circulating tumor cells ( sampled before operation at operation day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 30, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGMH-IRB-104-8753B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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