Recurrent Predictive Power of Circulating Tumor Cells for Non Small Cell Lung Cancer Patients

May 20, 2024 updated by: Chang Gung Memorial Hospital

Recurrent Predictive Power of Circulating Tumor Cells in Non Small Cell Lung Cancer Patients Who Receive Curative Resection

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 remains 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. The 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

Enrolling by invitation

Conditions

Detailed Description

Study subject:

Inclusion criteria 1. Patients with clinical stage 1 to 3a non-small lung cancer 2. Patients with a resectable suspicious pulmonary lesion which is difficult for pre-operation tissue prove or refused for pre-operation biopsy 3. Received curative intended tumor resection Exclusion criteria

  1. Small cell lung cancer component which identified in pathology
  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 pathology confirmation
  5. Patients who received neoadjuvant therapy

Data collection:

medical record review and blood sampling for circulating tumor cell purification

Timing of blood sampling:

a.Pre-operation, post-operation, post-operation day 1, post-operation day 3 b regular OPD surveillance (3 month-interval) for 3 years

Blood sampling: 20 ml blood that withdrawn from a peripheral vein

Circulating tumor cell purification: two-step procedure

  1. cell isolation: centrifugation, isolated karyocyte > 10 micrometer
  2. negative selection: wash out RBC, WBC depletion
  3. positive selection: purify circulating tumor cell (karyocyte which presented CD 45 negative, Epi-CAM positive, diameter greater 10 micrometer

Result analysis:

Combine the medical record to analyze the relationship between circulating tumor cells and disease relapse

Study Type

Observational

Enrollment (Estimated)

150

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)
Validation of 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.model establish model (case 1 to 50) versus validation group ( case 51-120) 3. need complete 5-years surveillance (disease status confirmation)
sequence patient recruitment for validation
1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.model establish model (case 1 to 50) versus validation group ( case 51-120) 3. need complete 5-years surveillance (disease status confirmation)

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
  • Principal Investigator: ChingFeng Wu, 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)

December 4, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (Actual)

October 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201701892B0

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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