Circulating Tumor DNA Longitudinal Monitoring in Stage III-IV Lung Cancer Patients
A Prospective Multicenter Study of Longitudinal Monitoring in Treated Stage III-IV Lung Cancer Patients by Circulating Tumor DNA
1 other identifier
observational
120
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2018
CompletedFirst Posted
Study publicly available on registry
September 11, 2018
CompletedStudy Start
First participant enrolled
November 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedNovember 13, 2018
November 1, 2018
1.5 years
September 7, 2018
November 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (3)
Assess the accuracy of ctDNA
1 year
Compared to conventional image
1 year
Compared to traditional tumor markers
6 months
Study Arms (3)
The chemotherapy cohort
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
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
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.
Eligibility Criteria
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
You may qualify if:
- 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;
You may not qualify if:
- Multiple primary lung cancer;
- Incorporating any unstable systemic disease;
- Histology is not NSCLC;
- Unqualified blood samples;
- Patients lacking any one of the detection points.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- First Hospital of Shijiazhuang Citylead
- Peking University People's Hospitalcollaborator
- Tianjin Medical University General Hospitalcollaborator
- Tianjin Medical University Cancer Institute and Hospitalcollaborator
- Affiliated Hospital of Hebei Universitycollaborator
- Hebei Medical University Fourth Hospitalcollaborator
- Xingtai People's Hospitalcollaborator
Study Sites (8)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000, China
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050011, China
The First Hospital of Shijiazhuang
Shijiazhuang, Hebei, 050011, China
Xingtai People's Hospital
Xingtai, Hebei, 054031, China
Handan Downtown Hospital
Handan, Heibe, 056001, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Biospecimen
Fresh tumor tissue and blood samples were collected from each patient. Histological specimens (fresh or paraffin blocks) of all enrolled patients before treatment need to be obtained, and according to different adjuvant therapy, blood samples were collected at a series of specific scheduled time-points
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan Zhang, M.D.
The First Hospital of Shijiazhuang
- STUDY CHAIR
Jun Wang, M.D.
Peking University People's Hospital
- STUDY DIRECTOR
Kezhong Chen, M.D.
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2018
First Posted
September 11, 2018
Study Start
November 9, 2018
Primary Completion
May 1, 2020
Study Completion
September 1, 2020
Last Updated
November 13, 2018
Record last verified: 2018-11