Clinical trial · Observational
Dynamic Monitoring Circulating Tumor DNA in Surgical Patients With Lung Cancer
A Study of the Value of Dynamic Monitoring Circulating Tumor DNA in Patients With Lung Cancer for Post-Operative Evaluation,Therapy Response Assessment,Relapse Prediction and Defining Molecular Phenotypes.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to promote the rational use of liquid biopsy in the clinical detection of lung cancer. Lung cancer is a malignant tumor with high morbidity and mortality worldwide. The incidence of lung cancer in China is expected to increase in the next few years with the aging population and environmental pollution. Early diagnosis and effective intervention are necessary in the clinical treatment of lung cancer. Surgical resection could achieve a better prognosis for patients with early lung cancer. However, for advanced lung cancer, individualized treatment based on the pathological classification, molecular genetic characteristics, and body conditions of patients could effectively prolong the lifetime. The prevention, diagnosis, and intervention strategies for lung cancer depend on the oncology information of patients. The techniques and methods used for detecting lung cancer in clinic include imaging technology, pathological biopsy, screening of blood tumor markers, and liquid biopsy technology, which has been developed recently. The liquid biopsy can capture the oncology information, including tumor load, tumor gene mutation, and so on, from the blood of patients with cancer by detecting circulating tumor cells, tumor exosome, circulating tumor DNA, and circulating tumor RNA. Moreover, it has become an important direction for clinical tumor detection because of its noninvasiveness, convenient sampling, and potential for overcoming tumor heterogeneity. This study intends to include 400 patients with stage I-III lung cancer to research on lung cancer diagnosis, drug efficacy, surgical effect evaluation, recurrence monitoring, prognosis judgment, medication guidance, and molecular classification differentiation through the dynamic detection of blood ctDNA using the second-generation sequencing technology. The study also intends to analyze and establish the database with a large sample size.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- patients with lung cancer
- description
- patients with stages I-III lung cancer eligible for surgery
Primary outcomes (1)
- measure
- recurrence-free survival
- timeFrame
- up to 36 months
- description
- from the date of surgery until the date of first verified recurrence or death from any cause
Secondary outcomes (2)
- measure
- overall survival
- timeFrame
- up to 36 months
- description
- from the date of surgery until the date of death from any cause
- measure
- heterogeneity of lung cancer
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with stage I-III lung cancer who are eligible for surgery(with no restriction of age, gender, or smoking history). 2. ECOG score:0-1. 3. Patients in the group will be allowed to collect whole blood or tissue samples at specific time points. 4. Patients will be regularly tested according to the doctor's advice. 5. Signed informed consent. Exclusion Criteria: 1. The tumor manifests as pure GGO on chest CT scan. 2. Patients for surgical biopsy. 3. Patients with serious mental disease. 4. Surgery is contraindicated for any reason.
References
Publications (16)
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- BACKGROUNDTsoi KK, Hirai HW, Chan FC, Griffiths S, Sung JJ. Cancer burden with ageing population in urban regions in China: projection on cancer registry data from World Health Organization. Br Med Bull. 2017 Jan 1;121(1):83-94. doi: 10.1093/bmb/ldw050. PMID 27913398
- BACKGROUNDGuo Y, Zeng H, Zheng R, Li S, Pereira G, Liu Q, Chen W, Huxley R. The burden of lung cancer mortality attributable to fine particles in China. Sci Total Environ. 2017 Feb 1;579:1460-1466. doi: 10.1016/j.scitotenv.2016.11.147. Epub 2016 Nov 29. PMID 27913022
- BACKGROUNDChansky K, Sculier JP, Crowley JJ, Giroux D, Van Meerbeeck J, Goldstraw P; International Staging Committee and Participating Institutions. The International Association for the Study of Lung Cancer Staging Project: prognostic factors and pathologic TNM stage in surgically managed non-small cell lung cancer. J Thorac Oncol. 2009 Jul;4(7):792-801. doi: 10.1097/JTO.0b013e3181a7716e. PMID 19458556
- BACKGROUNDPerez-Ramirez C, Canadas-Garre M, Robles AI, Molina MA, Faus-Dader MJ, Calleja-Hernandez MA. Liquid biopsy in early stage lung cancer. Transl Lung Cancer Res. 2016 Oct;5(5):517-524. doi: 10.21037/tlcr.2016.10.15. PMID 27826533
- BACKGROUNDGroome PA, Bolejack V, Crowley JJ, Kennedy C, Krasnik M, Sobin LH, Goldstraw P; IASLC International Staging Committee; Cancer Research and Biostatistics; Observers to the Committee; Participating Institutions. The IASLC Lung Cancer Staging Project: validation of the proposals for revision of the T, N, and M descriptors and consequent stage groupings in the forthcoming (seventh) edition of the TNM classification of malignant tumours. J Thorac Oncol. 2007 Aug;2(8):694-705. doi: 10.1097/JTO.0b013e31812d05d5.