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This is a prospective cohort study, which aims to evaluate the effectiveness and superiority of a novel minimal residual disease-guided prognosis monitoring and adjuvant treatment in stage IIA-IIIC non-small cell lung cancer.
This observational study is a single-center, prospective cohort study, which aims to detect minimal residual disease (MRD) using circulating tumor cells (CTC) and circulating tumor DNA (ctDNA). To evaluate the effectiveness and superiority of MRD detection, we enroll operable or inoperable IIA-IIIC stage NSCLC patients, and single-cell RNA sequencing and genomic sequencing would be performed for CTC and ctDNA, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operable group | Early-stage patients with radical surgery or operable patients with neoadjuvant treatment |
| |
| Inoperable group | Advanced-stage patients receive non-surgery therapies. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Operable | Procedure | Enrolled patients capable of surgical treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the Progression-free Survival (PFS) | Progression-free survival (PFS) is defined as the time from the start of treatment to the occurrence of tumor progression or death due to any cause based on RECIST 1.1 assessed by investigator review. | From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first), up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the Overall Survival (OS) | Overall Survival (OS) was measured from the date of first dose of study drug until date of death from any cause. Participants who were lost to follow-up and the participants who were alive at the date of data cutoff was censored at the date the participant was last known alive, whichever came earlier. | From the date of first dose of study drug until date of death from any cause (up to approximately 5 years ) |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 60 patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC would be enrolled from Jiangsu Cancer Institute & Hospital. In resectable group, we would enroll 20 early-stage cases and 20 operable patients for neoadjuvant treatment . In non-resectable group, 20 advanced-stage inoperable patients would be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Yin, M.D., Ph.D. | Contact | 18305185629 | rong_yin@njmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Institute & Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Peripheral whole blood
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |