Liquid Biopsy-Based Novel Modality for Postoperative Management of Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this trial
The goal of this study is to develop new techniques for minimal residual disease(MRD) monitoring and to confirm the efficacy and safety of MRD-guided postoperative management for early stage non-small cell lung cancer. The main questions this study aims to answer are:
* How to develop multi-omics-based high-sensitivity detection methods to accurately capture MRD and monitor postoperative recurrence in lung cancer? * Is adaptive treatment guided by ctDNA-MRD for lung cancer patients superior to traditional clinical management and effectively improves survival? * Do heterogeneous patient populations (grouped by stages, histopathological subtypes, driver mutations, and treatment histories) show differences in effects under ctDNA-MRD guided postoperative management strategies?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Non-small cell lung cancer with stage IA-IIIA (8th edition TNM classification) planning to undergo curative surgery or to undergo neoadjuvant therapy
Solid nodules >1 cm or ground-glass nodules >1.5 cm on imaging
No history of malignancies other than non-small cell lung cancer in the past 5 years
Specimens are well preserved and imaging documents are accessible.
Disqualifiers
Age<18 years old
Non-small cell lung cancer with pathologic stage IIIB-IV (8th edition TNM classification)
Pathology results confirmed not to be non-small cell lung cancer
History of malignancies other than non-small cell lung cancer in the past 5 years
Trial design
Design model
Parallel
Treatments tested in this trial
Adaptive postoperative management based on minimal residual disease
Other interventionparticipants will not receive postoperative treatment if (neoadjuvant therapy efficacy reaches pCR and) MRD results keep negative.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: adaptive postoperative management groupExperimental treatment 1 intervention
Group B: standard clinical postoperative management groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Two-year recurrence-free survival rate
The difference in the proportion of patients with (suspected) relapse or metastasis between the intervention group and the control group within two years.
Time frame
Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years.Secondary outcomes
1
Overall survival
The difference in overall survival between the intervention group and the control group.
Time frame
Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.2
Incremental cost effectiveness ratio
The cost of lung cancer-related treatment, including the cost of drugs, follow-up treatment, drug management costs (consultation fees, anti-tumor drug allocation fees, intravenous infusion fees, nursing fees, etc.), follow-up costs, laboratory tests and imaging examination costs, and the management costs of adverse reactions (1 cycle is counted as 1 time), and the per capita standard expenses calculated according to the Checkmate816 study protocol and China's expenses were used to calculate ICER.
Time frame
24 months after surgery3
Timely diagnosis rate by the novel MRD monitoring technique
The proportion of patients with recurrence signals detected by non-invasive methods prior to clinical confirmation of recurrence/metastasis, and quantify the mean lead time.
Time frame
two years4
Sensitivity of the novel MRD monitoring approach
Evaluate the sensitivity of the novel MRD-based assay against previous ctDNA-MRD-only approaches. Use receiver operating characteristic (ROC) curves and limit of detection (LoD) analyses for cross-platform comparison.
Time frame
two yearsSponsors and contacts
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Peking University People's Hospital
Lead sponsor
Peking University
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Jiangsu Cancer Institute & Hospital
Collaborator
Shanghai Chest Hospital
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
Shenzhen Third People's Hospital
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Peking University First Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
National Institute for Occupational Safety and Health (NIOSH/CDC)
Collaborator
Source ClinicalTrials.gov