Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma

NCT06476067 | Recruiting

• 1 other identifier: 23228/ESCC-Erec
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Esophageal Cancer; Recurrence; DNA Methylation

Outcome Measures

Primary Outcomes (1)

• Recurrence-free Survival（RFS)

  Time from curative-intent resection to the development of recurrence (or death)

  Up to 60 months

Study Arms (4)

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)

Procedure: Surgery

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)

Procedure: Surgery

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)

Procedure: Surgery

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)

Procedure: Surgery

Interventions

Surgery PROCEDURE

Esophagectomy

Patients with postoperative early tumor recurrence with ESCC （Training); Patients with postoperative early tumor recurrence with ESCC （Validation); Patients without postoperative early tumor recurrence with ESCC （Training); Patients without postoperative early tumor recurrence with ESCC （Validation)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had undergone complete esophagectomy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (2)

Nagoya University

Nagoya, Aichi-ken, 4668560, Japan

RECRUITING

Yamanashi Universiy

Chūō, Yamanashi, 4093898, Japan

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed and paraffin-embedded (FFPE) samples derived from resection tissue.

MeSH Terms

Conditions

Esophageal Neoplasms; Recurrence

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Koichi Takiguchi, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajay Goel, PhD

CONTACT

6262183452; AJGOEL@COH.ORG

Koichi Takiguchi, PhD

CONTACT

6262183452; ktakiguchi@coh.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: January 1, 2006
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

JP (2)