Clinical trial NCT06476067: Predicting Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma
Official title: Predicting Postoperative Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Recurrence
DNA Methylation
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had undergone complete esophagectomy.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence-free Survival（RFS)
timeFrame: Up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University
state: Aichi
city: Chuo
country: Japan
facility: Yamanashi Universiy
state: Yamanashi
Study officials:
affiliation: City of Hope Medical Center
name: Koichi Takiguchi, PhD
role: PRINCIPAL_INVESTIGATOR
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