Predicting early tumor recurrence in esophageal cancer patients
Predicting Postoperative Early Tumor Recurrence in Patients With Esophageal Squamous Cell Carcinoma
City of Hope Medical Center · NCT06476067
This study is testing if certain DNA patterns from tissue samples can help predict if esophageal cancer will come back early in patients who have had surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Nagoya, Aichi-ken and 1 other locations) |
| Trial ID | NCT06476067 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with esophageal squamous cell carcinoma (ESCC) who have undergone surgery. The researchers aim to identify biomarkers, specifically DNA methylation patterns, that can predict early tumor recurrence by analyzing whole genome DNA methylation from surgical specimens. Given that approximately 40% of patients experience recurrence within two years post-surgery, this study seeks to improve prognostic capabilities and potentially guide further treatment decisions. The study will involve patients who have had complete esophagectomy and have available tissue samples for analysis.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed ESCC who have undergone complete esophagectomy without prior chemotherapy or radiotherapy.
Not a fit: Patients with multiple cancers or those lacking clinical information within two years of surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of tumor recurrence, allowing for timely interventions and better patient outcomes.
How similar studies have performed: While the use of DNA methylation as a biomarker is gaining traction, this specific approach to predict early recurrence in ESCC is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nagoya, Aichi-ken and 1 other locations
- Nagoya University — Nagoya, Aichi-ken, Japan (RECRUITING)
- Yamanashi Universiy — Chūō, Yamanashi, Japan (RECRUITING)
Study contacts
- Principal investigator: Koichi Takiguchi, PhD — City of Hope Medical Center
- Study coordinator: Ajay Goel, PhD
- Email: AJGOEL@COH.ORG
- Phone: 6262183452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophageal Cancer, Recurrence, DNA Methylation