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The prognosis of patients with esophageal squamous cell carcinoma (ESCC) who develop post-operative early tumor recurrence is often relatively poor. Therefore, biomarker that can detect micro metastases before the start of treatment is required. Epigenomic alterations such as DNA methylation have attracted attention as promising biomarkers. The investigators aim to predict early recurrence based on whole genome DNA methylation analysis of esophageal cancer.
Prognosis for patients with esophageal squamous cell carcinoma (ESCC) remains poor. Surgery is one of the standard treatments for patients with ESCC who are considered to have a curative resection, however, approximately 40% of patients develop tumor recurrence within two years after surgery. The main cause of poor prognosis in ESCC patients undergoing surgery is postoperative tumor recurrence due to the presence of latent micro-metastases at the time of surgery. Even with today's advances in preoperative diagnostic techniques, predicting early tumor recurrence remains difficult due to the lack of established methods. Epigenetic markers, especially DNA methylation, are considered ideal markers for predicting cancer metastasis due to their cancer-specific methylation patterns, biological stability, and technical reproducibility. Our study aims to evaluate methylation of surgical specimens to assess residual disease and predict early recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with postoperative early tumor recurrence with ESCC （Training) | Patients with early tumor recurrence defined as patients who developed tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP) |
| |
| Patients without postoperative early tumor recurrence with ESCC （Training) | Patients without early tumor recurrence defined as patients who did not develope tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP) |
| |
| Patients with postoperative early tumor recurrence with ESCC （Validation) | Patients with early tumor recurrence defined as patients who developed tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP) |
| |
| Patients without postoperative early tumor recurrence with ESCC （Validation) | Patients without early tumor recurrence defined as patients who did not develope tumor recurrence within 2 years after esophagectomy A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Esophagectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free Survival（RFS) | Time from curative-intent resection to the development of recurrence (or death) | Up to 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who had undergone complete esophagectomy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ajay Goel, PhD | Contact | 6262183452 | AJGOEL@COH.ORG | |
| Koichi Takiguchi, PhD | Contact | 6262183452 | ktakiguchi@coh.org |
| Name | Affiliation | Role |
|---|---|---|
| Koichi Takiguchi, PhD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University | Recruiting | Nagoya | Aichi-ken | 4668560 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18695138 | Background | Brown LM, Devesa SS, Chow WH. Incidence of adenocarcinoma of the esophagus among white Americans by sex, stage, and age. J Natl Cancer Inst. 2008 Aug 20;100(16):1184-7. doi: 10.1093/jnci/djn211. Epub 2008 Aug 11. | |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Formalin-fixed and paraffin-embedded (FFPE) samples derived from resection tissue.
| Yamanashi Universiy | Recruiting | Chūō | Yamanashi | 4093898 | Japan |
|
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |