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

NCT03721133 | Enrolling By Invitation DMC

• 1 other identifier: 201701892B0
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Lung Cancer Recurrent

Outcome Measures

Primary Outcomes (2)

• Variation trend of circulating tumor cell counts

  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

  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)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a resectable malignant or suspicious malignant pulmonary lesion

You may qualify if:

• Non-small cell lung cancer patients with stage I to III
• Patients with resectable suspicious pulmonary malignant lesion
• no pre-operation diagnosis ( patients refused biopsy or difficult for biopsy)
• image survey showed clinical stage I to III

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (23)

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  PMID: 40294350 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 26, 2018
• Study Start: December 4, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-03

Locations

TW (1)