Clinical trial NCT03664843: Circulating Tumor DNA Longitudinal Monitoring in Stage III-IV Lung Cancer Patients
Official title: A Prospective Multicenter Study of Longitudinal Monitoring in Treated Stage III-IV Lung Cancer Patients by Circulating Tumor DNA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma
Non-small Cell Lung Cancer
Lung Neoplasm
Keywords: circulating tumor DNA
lung cancer
surveillance
longitudinal monitoring
lead time
Lead sponsor: First Hospital of Shijiazhuang City
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
name: Tianjin Medical University General Hospital
name: Tianjin Medical University Cancer Institute and Hospital
name: Affiliated Hospital of Hebei University
name: Hebei Medical University Fourth Hospital
name: Xingtai People's Hospital
First posted: 2018-09-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be drawn from Oncology Department of multicenters. The enrolled patients must be patients with stage III-IV NSCLC according to the 8th edition of the TNM Classification of the International Association for the Study of Lung Cancer (IASLC), must be greater than 18 years old and must have the tissue specimens (fresh or wax blocks) before this treatment. The exclusion criteria are as followed: (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. All of the patients signing informed consent were not involved in the recruitment and conduct of the study

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ctDNA effective time
timeFrame: 6 months
measure: ctDNA leading time
timeFrame: 1 year
Secondary outcomes:
measure: Assess the accuracy of ctDNA
timeFrame: 1 year
measure: Compared to conventional image
timeFrame: 1 year
measure: Compared to traditional tumor markers
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The First Hospital of Shijiazhuang
state: Hebei
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Handan
country: China
facility: Handan Downtown Hospital
state: Heibe
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: The First Hospital of Shijiazhuang
name: Yan Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University People's Hospital
name: Jun Wang, M.D.
role: STUDY_CHAIR
affiliation: Peking University People's Hospital
name: Kezhong Chen, M.D.
role: STUDY_DIRECTOR
References: