Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06476067

Predicting 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagoya University, Nagoya, Aichi-ken, Japan

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Surgery

Procedure

Esophagectomy

Primary outcomes

  1. Recurrence-free Survival(RFS)

    Time frame: Up to 60 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ajay Goel, PhD

CONTACT

[email protected]

6262183452

Koichi Takiguchi, PhD

CONTACT

[email protected]

6262183452

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.