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The goal of this observational study or is to explore the correlation between dynamic changes in postoperative circulating tumor DNA (ctDNA) and recurrence risk using a novel, tumor-informed ctDNA detection technique, thus laying the foundation for further promoting ctDNA detection to guide postoperative adjuvant therapy decisions. This study focuses on patients with esophageal squamous cell carcinoma who did not achieve pCR following neoadjuvant therapy combined with surgical resection. The main question it aims to answer is:
Is there a correlation between postoperative ctDNA changes and tumor recurrence?
Participants will be asked to undergo postoperative ctDNA detection.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| molecular residual disease detection | Diagnostic Test | ctDNA detection |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the recurrence of patients and the quantitative measurement of circulating tumor DNA (ctDNA) concentration. | Correlation were evaluated based on the sensitivity and specificity of ctDNA in predicting recurrence.The sensitivity and specificity were determined by evaluating the association between positive ctDNA and tumor recurrence. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative molecular residual disease (MRD) positive rate | 3 years | |
| Correlation between ctDNA detection and postoperative adjuvant therapy. | The ctDNA assay was employed to inform postoperative adjuvant therapy, with the objective of determining its potential to enhance patient prognosis. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with esophageal squamous cell carcinoma who have not achieved pCR following neoadjuvant chemoradiotherapy and surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Yang, MD | Contact | 86-020-87343932 | 020-87343932 | yanghong@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hong Yang, M.D.;Ph.D. | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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blood
| 3 years |
| correlation between patients' prognosis and landmark MRD status | The sensitivity and specificity were determined by evaluating the association between positive landmark MRD status and patients' prognosis. | 3 years |
| 2-year disease-free survival | 2 years |
| 3-year disease-free survival | 3 years |
| 5-year disease-free survival | 5 years |
| 2-year overall survival | 2 years |
| 3-year overall survival | 3 years |
| 5-year overall survival | 5 years |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |