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Molecular residual disease (MRD) has strong relationship with clinical outcome in multiple solid tumors. Here, the investigators try to verify the negative predictive value of undetectable MRD, which is considered as a superior prognostic factor for resected NSCLC patients, and not requiring excessive adjuvant therapy. Stage IB-IIIA resected NSCLC patients with landmark and longitudinal undetectable MRD are enrolled and under close surveillance in this study.
Stage IB-IIIA resected NSCLC patients will undergo two-round MRD tests after operation, first in 3-7 days and second in 1 month after operation. And patients who confirm two-round landmark undetectable MRD will be enrolled. Enrolled patients will be under close MRD and imaging monitoring without any adjuvant therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Undetectable MRD | Stage IB-IIIA NSCLC patients who after complete resection. And patients who maintain MRD negativity in two-round MRD landmark test (first in 3-7 days after surgery, second in 1 months ±7 days after surgery) will be enrolled. And patients will be under close dynamic monitoring at least two years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molecular residual disease test | Diagnostic Test | OncoMRD Lung |
|
| Measure | Description | Time Frame |
|---|---|---|
| Two-years disease free survival rates for patients with longitudinal undetectable MRD | The 2-year DFS rate of patients who maintain 2-years undetectable MRD. | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Two-years disease free survival rates for patients with six months longitudinal undetectable MRD | The 2-year DFS rate of patients who maintain 6-months undetectable MRD. | 2 year |
| Two-years disease free survival rates for patients with 12-months longitudinal undetectable MRD |
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Inclusion Criteria:
Exclusion Criteria:
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Stage IB-IIIA NSCLC patients who after complete resection and undetectable landmark MRD.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi-Long Wu, M.D | Contact | 020-83827812 | syylwu@live.cn | |
| Xue-Ning Yang, Ph.D | Contact | 020-83827812 | yangxuening@gdph.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences | Recruiting | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35543554 | Background | Zhang JT, Liu SY, Gao W, Liu SM, Yan HH, Ji L, Chen Y, Gong Y, Lu HL, Lin JT, Yin K, Jiang BY, Nie Q, Liao RQ, Dong S, Guan Y, Dai P, Zhang XC, Yang JJ, Tu HY, Xia X, Yi X, Zhou Q, Zhong WZ, Yang XN, Wu YL. Longitudinal Undetectable Molecular Residual Disease Defines Potentially Cured Population in Localized Non-Small Cell Lung Cancer. Cancer Discov. 2022 Jul 6;12(7):1690-1701. doi: 10.1158/2159-8290.CD-21-1486. | |
| 42266691 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Every MRD test will take 20ml peripheral blood for DNA extraction.
The 2-year DFS rate of patients who maintain 12-months undetectable MRD. |
| 2 year |
| Two-years disease free survival rates for patients with 18-months longitudinal undetectable MRD | The 2-year DFS rate of patients who maintain 18-months undetectable MRD. | 2 year |
| Two-years event-free survival rates for enrolled patients in two years | The events are defined as disease recurrence or detectable MRD. | 2 year |
| Derived |
| Huang Z, He J, Li Y, Xu Z, Peng H, Gao X, Zhou H, Guo J, Yang N. Non-invasive radiogenomic mapping of the SMARCAL1-driven ferroptotic niche is associated with longitudinal MRD-negative surveillance in early-stage NSCLC. Front Immunol. 2026 May 25;17:1835413. doi: 10.3389/fimmu.2026.1835413. eCollection 2026. |
| 37880076 | Derived | Zhang JT, Dong S, Gu WQ, Zhao N, Liang Y, Tang WF, Liu SY, Wang F, Wang GS, Peng B, Wu N, Yan S, Geng GJ, Xie ZF, Yang YL, Zhang JH, Zhang T, Yang N, Jiao WJ, Xiong YY, Cai M, Li F, Chen RR, Yan HH, Maggie Liu SY, Yi X, Zhong WZ, Yang XN, Wu YL. Adjuvant Therapy-Free Strategy for Stage IB to IIIA Non-Small-Cell Lung Cancer Patients After Radical Resection Based on Longitudinal Undetectable Molecular Residual Disease: Prospective, Multicenter, Single-Arm Study (CTONG 2201). Clin Lung Cancer. 2024 Jan;25(1):e1-e4. doi: 10.1016/j.cllc.2023.09.008. Epub 2023 Oct 6. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |