A Prospective Multicenter Study of Longitudinal Monitoring in Treated Stage III-IV Lung Cancer Patients by Circulating Tumor DNA
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma
- Sponsor
- First Hospital of Shijiazhuang City
- Enrollment
- 120
- Locations
- 8
- Primary Endpoint
- ctDNA leading time
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
ctDNA leading time
Time Frame: 1 year
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.
ctDNA effective time
Time Frame: 6 months
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.
Secondary Outcomes
- Compared to conventional image(1 year)
- Compared to traditional tumor markers(6 months)
- Assess the accuracy of ctDNA(1 year)