Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma

July 10, 2026 updated by: City of Hope Medical Center

Predicting Postoperative Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who had undergone complete esophagectomy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)
Procedure: Surgery
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)
Procedure: Surgery
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)
Procedure: Surgery
Esophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free Survival（RFS)
Time Frame: Up to 60 months
Time from curative-intent resection to the development of recurrence (or death)
Up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Koichi Takiguchi, PhD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Estimated)

June 18, 2028

Study Completion (Estimated)

June 18, 2028

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/ESCC-Erec

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe