Actively Recruiting

Phase Not Applicable
Age: 20Years - 90Years
All Genders
ID06262386

Utilizing Circulating Tumor Cell Changes and Tumor Pathology to Predict Early Relapse in Resectable Non-Small Cell Lung Cancer Patients: A Prospective Clinical Feasibility Trial

Led by Chang Gung Memorial Hospital · Updated on 2024-02-16

358

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Chang Gung Memorial Hospital

Lead Sponsor

N

National Science and Technology Council

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to improve the identification of patients with resectable non-small cell lung cancer who are at risk of early relapse after tumor removal. Early relapse significantly affects survival, yet current imaging and screening methods cannot reliably predict which patients will experience it. By studying circulating tumor cells (CTCs) and tumor pathology, the trial seeks to better select patients for adjuvant therapy to reduce early relapse. The study uses a combined relapse prediction model that tracks changes in circulating tumor cells around the time of surgery and examines tumor pathology. Patients identified as high risk based on these factors may receive cisplatin-based chemotherapy as adjuvant therapy following surgery. The study follows recommended guidelines for adjuvant treatment and observes patients over time to assess outcomes. Participants will undergo blood sampling to monitor circulating tumor cells and regular clinical surveillance at three-month intervals. Researchers will measure the accuracy of the relapse prediction model and early relapse rates, as well as overall survival, through ongoing follow-up. The study monitors participants from surgery through treatment and regular check-ups until the study concludes in 2028.

CONDITIONS

Brief Title

Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial

Who Can Participate

Age: 20Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with resectable lung cancer at clinical stage 1a to 3a
  • Patients who have undergone tumor resection surgery
Not Eligible

You will not qualify if you...

  • Pathologic stage greater than 3b or stage 4
  • Pathologic stage less than 1a1
  • Inability to complete the treatment course
  • Unable to have blood samples taken for circulating tumor cell monitoring or regular surveillance visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - As recommended by NCCN guidelines following surgery

Participants identified at high risk of relapse after surgery receive cisplatin based chemotherapy as adjuvant therapy to reduce disease relapse.

Visits scheduled according to chemotherapy cycles

Monitoring

Duration - Follow-up at 3 month intervals up to study completion

Participants are monitored regularly to assess relapse and overall survival using circulating tumor cell measurements and clinical evaluations.

Follow-up visits every 3 months

Trial Site Locations

Total: 1 location

1

Ching-Yang Wu

Taoyuan City, Taiwan, 333

Actively Recruiting

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Research Team

C

Ching-Yang Wu

C

Chia-Tsun CH Hsieh

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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Published Research Related To This Trial

Pathologic Stage of Nonsmall Cell Lung Cancer Patients Presenting as Resectable Cases After Neoadjuvant Therapy Did Not Predict the Prognosis.

Ching-Yang Wu, Jui-Ying Fu, Ching-Feng Wu...

https://pubmed.ncbi.nlm.nih.gov/26448022

Application of the noise power spectrum in modern diagnostic MDCT: part I. Measurement of noise power spectra and noise equivalent quanta.

K L Boedeker, V N Cooper, M F McNitt-Gray

https://pubmed.ncbi.nlm.nih.gov/17664593

Detection of nodules showing ground-glass opacity in the lungs at low-dose multidetector computed tomography: phantom and clinical study.

Yoshinori Funama, Kazuo Awai, Duo Liu...

https://pubmed.ncbi.nlm.nih.gov/19188784