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

First Hospital of Shijiazhuang City

Status: Unknown

Conditions: Non-small Cell Lung Cancer; Carcinoma; Lung Neoplasm

Study type: Observational

Funder types: Other

Identifiers

NCT03664843

PTH01801

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Greater than 18 years old;
2. Patients with stage III-IV NSCLC;
3. Have the tissue specimens (fresh or wax blocks) before this treatment;
4. PS<=2 in radiotherapy/ chemotherapy group; PS<=3 in targeted therapy group
5. Signing informed consent;

Exclusion criteria

1. Multiple primary lung cancer;
2. Incorporating any unstable systemic disease;
3. Histology is not NSCLC;
4. Unqualified blood samples;
5. Patients lacking any one of the detection points.

Trial design

120 participants in 3 patient groups

The chemotherapy cohort

Description:

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

Description:

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

Description:

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.