Non-small Cell Lung Cancer Clinical Trial
Official title:
A Prospective Multicenter Study of Longitudinal Monitoring in Treated Stage III-IV Lung Cancer Patients by Circulating Tumor DNA
Conduct a prospective study in multicenter to confirm the value of circulating tumor DNA in longitudinal monitoring of stage III-IV lung cancer patients.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 1, 2020 |
Est. primary completion date | May 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Hebei University | Baoding | Hebei |
China | Peking University People's Hospital | Beijing | Beijing |
China | Handan Downtown Hospital | Handan | Heibe |
China | Hebei Medical University Fourth Hospital | Shijiazhuang | Hebei |
China | The First Hospital of Shijiazhuang | Shijiazhuang | Hebei |
China | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin |
China | Tianjin Medical University General Hospital | Tianjin | Tianjin |
China | Xingtai People's Hospital | Xingtai | Hebei |
Lead Sponsor | Collaborator |
---|---|
First Hospital of Shijiazhuang City | Affiliated Hospital of Hebei University, Hebei Medical University Fourth Hospital, Peking University People's Hospital, Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University General Hospital, Xingtai People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Assess the accuracy of ctDNA | To assess the accuracy of ctDNA when imaging undetectable or difficult to assess | 1 year | |
Secondary | 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 | |
Secondary | 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 |
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