Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma

NCT ID: NCT06476067

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-01

Study Completion Date

2026-06-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Esophageal Cancer Recurrence DNA Methylation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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)

Surgery

Intervention Type PROCEDURE

Esophagectomy

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)

Surgery

Intervention Type PROCEDURE

Esophagectomy

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)

Surgery

Intervention Type PROCEDURE

Esophagectomy

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)

Surgery

Intervention Type PROCEDURE

Esophagectomy

Interventions

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Surgery

Esophagectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Koichi Takiguchi, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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Nagoya University

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Yamanashi Universiy

Chūō, Yamanashi, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Ajay Goel, PhD

Role: CONTACT

6262183452

Koichi Takiguchi, PhD

Role: CONTACT

6262183452

Facility Contacts

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Fuminori Sonohara, PhD

Role: primary

Katsutoshi Shoda, PhD

Role: primary

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Other Identifiers

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23228/ESCC-Erec

Identifier Type: -

Identifier Source: org_study_id

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