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The conception of molecular residual disease (MRD) extending from hematologic tumor to solid tumors. Evidences supporting MRD evaluation for lung cancer by liquid biopsy has gradually accumulated, especially circulating tumor DNA (ctDNA). In this observational study, the investigators prospectively enroll stage I-IIIA non-small cell lung cancer (NSCLC) patients who underwent complete resection. Preoperative blood sample, tumor tissue and dynamic postoperative blood samples are collected continuously for MRD detection. This study aim to explore the prognostic value of MRD for stage I-IIIA NSCLC patients after complete resection.
There will be a rapid surge in research about molecular residual disease (MRD) for solid cancer in the near future. However, MRD differed significantly between tumor types and between contexts; there continues to be a considerable lack of awareness and knowledge about using MRD in lung cancer. Hence, this study aims to investigate the value of MRD in NSCLC patients who underwent complete resection. Preoperative blood sample (20ml), tumor tissue and dynamic postoperative blood samples (20ml) are collected continuously for MRD detection. The follow-up was performed once every 3 to 6 months. The primary objective of this study is to assess the prognostic value of MRD for stage I-IIIA NSCLC patients after complete resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I-IIIA NSCLC patients after complete resection | For stage I-IIIA NSCLC patients who underwent complete resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRD detection | Diagnostic Test | The Geneplus OncoMRD lung assay is used to detect the MRD status. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The prognostic value of MRD | The survival difference between MRD positive and MRD negative patients. | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| The predictive value of MRD | The separative value adjuvant chemotherapy or target therapy in MRD positive population and MRD negative population. | 5 year |
| The lead time of MRD | The median lead time of detectable MRD before regular imaging finding. |
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Inclusion Criteria:
Exclusion Criteria:
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The pathological diagnosis confirmed stage I-IIIA NSCLC patients who underwent complete resection. No history of other malignant tumors within 5 years.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xue-Ning Yang, Ph.D | Contact | 020-83827812-51311 | yangxuening@gdph.org.cn | |
| Jia-Tao Zhang, Ph.D | Contact | 020-83827812-51311 | Z18820792959@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Lung Cancer Institute & Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30796368 | Background | Pantel K, Alix-Panabieres C. Liquid biopsy and minimal residual disease - latest advances and implications for cure. Nat Rev Clin Oncol. 2019 Jul;16(7):409-424. doi: 10.1038/s41571-019-0187-3. | |
| 29968853 | Background | Abbosh C, Birkbak NJ, Swanton C. Early stage NSCLC - challenges to implementing ctDNA-based screening and MRD detection. Nat Rev Clin Oncol. 2018 Sep;15(9):577-586. doi: 10.1038/s41571-018-0058-3. |
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The IPD could be shared after seeking consent from the corresponding investigator.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Plasma cell free DNA
| 5 year |
| 28899864 | Background | Chaudhuri AA, Chabon JJ, Lovejoy AF, Newman AM, Stehr H, Azad TD, Khodadoust MS, Esfahani MS, Liu CL, Zhou L, Scherer F, Kurtz DM, Say C, Carter JN, Merriott DJ, Dudley JC, Binkley MS, Modlin L, Padda SK, Gensheimer MF, West RB, Shrager JB, Neal JW, Wakelee HA, Loo BW Jr, Alizadeh AA, Diehn M. Early Detection of Molecular Residual Disease in Localized Lung Cancer by Circulating Tumor DNA Profiling. Cancer Discov. 2017 Dec;7(12):1394-1403. doi: 10.1158/2159-8290.CD-17-0716. Epub 2017 Sep 24. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |