Tracking multigene methylation changes to monitor treatment response in esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, multicenter study measures circulating multigene methylation levels before and after initial therapy in adults with non-metastatic esophageal cancer and compares those changes to objective response on contrast-enhanced CT/MRI and serum tumor markers. The primary analysis correlates pretreatment-to-posttreatment methylation shifts with objective response rate (ORR). Secondary analyses examine whether methylation fluctuation patterns relate to progression-free survival, compare diagnostic accuracy against conventional biomarkers, and explore using methylation thresholds to guide adaptive therapy changes. Participants are treatment-naive adults with histologically confirmed esophageal carcinoma enrolled at participating Chinese hospitals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Age at initial diagnosis: 18-75 years (inclusive) Confirmed diagnosis: Histologically proven esophageal carcinoma with complete medical records, including (a) definitive pathological diagnosis report, (b) TNM staging per AJCC 8th edition criteria Cancer history: No prior malignancies at other anatomical sites (excluding cured non-melanoma skin cancers/carcinoma in situ) Metastasis status: Radiologically confirmed absence of distant metastases in liver, lungs, or other organs via contrast-enhanced CT/MRI and whole-body bone scan within 4 weeks before enrollment Treatment-naïve status: No previous exposure to (i) esophageal resection surgery, (ii) systemic chemotherapy, (iii) thoracic radiation therapy (\>10 Gy), or (iv) PD-1/PD-L1 immune checkpoint inhibitors

Exclusion Criteria:

Life expectancy \<6 months (as assessed by ECOG score ≥4 or Palliative Performance Scale ≤30%) Cognitive/psychiatric conditions: a. Legally incapacitated individuals without legal guardians, b. Active psychotic disorders (e.g., schizophrenia, bipolar disorder) or dementia (MMSE score \<24) Investigator-determined exclusions

Where it's running

• Gansu Wuwei Cancer Hospital
  Wuwei, Gansu, China Recruiting
• Zhaoqing Gaoyao District People's Hospital
  Zhaoqing, Guangdong, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• Xijing Hospital
  Xi'an, Shaanxi, China Recruiting
• General Hospital of Western Theater Command, People's Liberation Army (PLA)
  Chengdu, Sichuan, China Recruiting
• Cancer Hospital Affiliated to Shantou University Medical College
  Shantou, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: Zhongyang Zhang
• Email: 18831363219@163.com
• Phone: +86 188 3136 3219

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.