Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma

Recruiting

• Conditions: Recurrence; Esophageal Cancer; DNA Methylation
• Interventions: Procedure: Surgery

• Registration Number: NCT06476067
• Lead Sponsor: City of Hope Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-01-01
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-06-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Patients who had histologically confirmed ESCC.
2. Patients who had undergone only complete esophagectomy with radical lymph node dissection without chemotherapy or radiotherapy before or after surgery.
3. Patients for whom tissue samples are available
4. Patients who were followed-up completely, with information on observation periods of at least 2 years after surgery.
5. Written informed consent following full study information is provided to the patient.

Exclusion Criteria

1. Patients lacking clinical information within 2 years of surgery.
2. Patients with multiple cancers.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients without postoperative early tumor recurrence with ESCC （Validation)	Surgery	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)	Surgery	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 with postoperative early tumor recurrence with ESCC （Training)	Surgery	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)	Surgery	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)

Primary Outcome Measures

Name	Time	Method
Recurrence-free Survival（RFS)	Up to 60 months	Time from curative-intent resection to the development of recurrence (or death)

Trial Locations

Locations (2)

Yamanashi Universiy; 🇯🇵 Chuo, Yamanashi, Japan

Nagoya University; 🇯🇵 Nagoya, Aichi, Japan