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Recruiting NCT06930807

Liquid Biopsy-Based Novel Modality for Postoperative Management of Lung Cancer

No phase Interventional Non-small Cell Lung Cancer Minimal Residual Disease Adaptive Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adaptive postoperative management based on minimal residual disease.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer, Minimal Residual Disease, Adaptive Treatment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Development and Validation of Non-Invasive Monitoring Techniques for Postoperative Recurrence and Novel Adjuvant Therapeutic Strategies in Lung Cancer

Overview

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?

Detailed description

Approximately 30% of early-stage lung cancer patients experience recurrence after curative surgery. However, the clinical utility of routine chest CT surveillance remains limited. Emerging evidence has demonstrated that liquid biopsy-based minimal residual disease (MRD) detection may serve as a more sensitive monitoring strategy. Longitudinal ctDNA dynamics analysis further enables real-time assessment of tumor progression and early detection of molecular relapse.

This study aims to develop a novel multidimensional approach for non-invasive postoperative recurrence monitoring in lung cancer and establish an MRD-guided adjuvant therapy model to optimize precision treatment and MRD-stratified follow-up protocols for lung cancer patients. This study will evaluate the sensitivity and specificity of novel monitoring methods and further compare emerging non-invasive recurrence monitoring approaches with conventional ctDNA-based techniques, driving continuous advancements in lung cancer research.

Interventions

  • Other Adaptive postoperative management based on minimal residual disease
    participants will not receive postoperative treatment if (neoadjuvant therapy efficacy reaches pCR and) MRD results keep negative.

Primary outcome measures

  • Two-year recurrence-free survival rate [Time frame: Time from curative surgery to confirmation of clinical progression (recurrence or metastasis) within two years.]
Secondary outcome measures (4)
  • Overall survival [Time frame: Time from curative surgery to confirmation of death (any cause)，assessed up to 60 months.]
  • Incremental cost effectiveness ratio [Time frame: 24 months after surgery]
  • Timely diagnosis rate by the novel MRD monitoring technique [Time frame: two years]
  • Sensitivity of the novel MRD monitoring approach [Time frame: two years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University People's Hospital — Beijing

Identifiers

NCT: NCT06930807 · 2023ZD0501900

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗