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Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06476067
Enrollment
150
Registered
2024-06-26
Start date
2006-01-01
Completion date
2028-06-18
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DNA Methylation, Esophageal Cancer, Recurrence

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.

Interventions

PROCEDURESurgery

Esophagectomy

Sponsors

City of Hope Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence-free Survival(RFS)Up to 60 monthsTime from curative-intent resection to the development of recurrence (or death)

Countries

Japan

Contacts

CONTACTAjay Goel, PhD
AJGOEL@COH.ORG6262183452
CONTACTKoichi Takiguchi, PhD
ktakiguchi@coh.org6262183452
PRINCIPAL_INVESTIGATORKoichi Takiguchi, PhD

City of Hope Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026