Circulating Tumor DNA Longitudinal Monitoring in Stage III-IV Lung Cancer Patients

Study Overview
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Brief Summary
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Conduct a prospective study in multicenter to confirm the value of circulating tumor DNA in longitudinal monitoring of stage III-IV lung cancer patients.

Detailed Description
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The study consists of two phases, the first stage is the exploratory stage of blood collection point which is the appropriate effective time after chemotherapy, radiotherapy, targeted therapy. The second phase, which is the expansion of the first phase, is to determine the precise leading time of ctDNA relative to tumor biomarkers or image evaluation in determining the efficacy of advanced NSCLC cancer therapy. Both stages were divided into three subgroups: the chemotherapy group, the radiotherapy group, and the targeted therapy group.

Official Title
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A Prospective Multicenter Study of Longitudinal Monitoring in Treated Stage III-IV Lung Cancer Patients by Circulating Tumor DNA

Conditions
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Carcinoma, Non-small Cell Lung Cancer, Lung Neoplasm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than 18 years old; Patients with stage III-IV NSCLC; Have the tissue specimens (fresh or wax blocks) before this treatment; PS<=2 in radiotherapy/ chemotherapy group; PS<=3 in targeted therapy group Signing informed consent; Exclusion Criteria: Multiple primary lung cancer; Incorporating any unstable systemic disease; Histology is not NSCLC; Unqualified blood samples; Patients lacking any one of the detection points.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The chemotherapy cohort<br>Blood samples for ctDNA and biomarkers analysis are collected at before chemotherapy and at a series of scheduled time-points after chemotherapy , with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed. | |
| The radiotherapy cohort<br>Blood samples for ctDNA and biomarkers analysis are collected at before radiotherapy and at a series of scheduled time-points after radiotherapy, with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed. | |
| The targeted therapy cohort<br>Blood samples for ctDNA and biomarkers analysis are collected at before targeted therapy and at a series of scheduled time-points after targeted therapy, with serial two-weekly blood samples collected from a subset of patients. Meanwhile, imaging technology such as CT scan detection would be performed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ctDNA effective time | To explore the appropriate chemo/ radio/ target effective time (CET/RET/TET) through measurement and monitoring of ctDNA after anti-cancer therapies in advanced NSCLC. | 6 months | 
| ctDNA leading time | To investigate the precise leading time for ctDNA compared to conventional biomarker or image evaluation in detecting disease recurrence after radiotherapy, chemotherapy, or targeted therapy respectively. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the accuracy of ctDNA | To assess the accuracy of ctDNA when imaging undetectable or difficult to assess | 1 year | 
| Compared to conventional image | Compared to conventional image evaluation, to determine the consistency of ctDNA in treatment response of measurable lesion after radiotherapy, chemotherapy, or targeted therapy respectively | 1 year | 
| Compared to traditional tumor markers | To explore the consistency for ctDNA in determining the efficacy of advanced NSCLC compared to tumor markers after radiotherapy, chemotherapy, or targeted therapy respectively | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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longitudinal monitoring, lead time, circulating tumor DNA, lung cancer, surveillance