Carcinoma, Lung Neoplasm, Non-small Cell Lung Cancer
Conditions
Keywords
circulating tumor DNA, lung cancer, surveillance, longitudinal monitoring, lead time
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.
Interventions
None listed
Sponsors
Peking University People's Hospital
Tianjin Medical University General Hospital
Tianjin Medical University Cancer Institute and Hospital
Affiliated Hospital of Hebei University
Hebei Medical University Fourth Hospital
Xingtai People's Hospital
First Hospital of Shijiazhuang City
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ctDNA effective time | 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. |
| ctDNA leading time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the accuracy of ctDNA | 1 year | To assess the accuracy of ctDNA when imaging undetectable or difficult to assess |
| Compared to conventional image | 1 year | Compared to conventional image evaluation, to determine the consistency of ctDNA in treatment response of measurable lesion after radiotherapy, chemotherapy, or targeted therapy respectively |
| Compared to traditional tumor markers | 6 months | To explore the consistency for ctDNA in determining the efficacy of advanced NSCLC compared to tumor markers after radiotherapy, chemotherapy, or targeted therapy respectively |
Countries
China
Contacts
Primary ContactYan Zhang, M.D.
Backup ContactKezhong Chen, M.D.
Outcome results
None listed