Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma
Recruiting now
Conditions studied: Esophageal Cancer
In brief
The primary objective is to determine whether pretreatment-to-posttreatment changes in circulating multigene methylation levels correlate with objective response rates (ORR) assessed by contrast-enhanced CT/MRI and levels of serum tumor markers. Secondary endpoints include: (a) time-dependent association between methylation fluctuation patterns and progression-free survival (PFS), (b) comparative diagnostic accuracy of methylation indices versus conventional biomarkers, and (c) feasibility of using methylation thresholds to guide adaptive therapy modification.
Key facts
- Study ID
- NCT06979869
- Run by
- Xijing Hospital
- People needed
- 300
- Starts
- 2025-05-26
- Expected to finish
- 2030-03-01
- Last updated by the study team
- 2025-12-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Gansu Wuwei Cancer Hospital — Wuwei, Gansu, China (enrolling)
- Zhaoqing Gaoyao District People's Hospital — Zhaoqing, Guangdong, China (enrolling)
- Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
- Xijing Hospital — Xi'an, Shaanxi, China (enrolling)
- General Hospital of Western Theater Command, People's Liberation Army (PLA) — Chengdu, Sichuan, China (enrolling)
- Cancer Hospital Affiliated to Shantou University Medical College — Shantou, Guangdong, China
- The First Affiliated Hospital of Shanxi Medical University — Taiyuan, Shanxi, China
- The First Affiliated Hospital of Yan'an University — Yan’an, Shaanxi, China
- Tangdu Hospital — Xi'an, Shaanxi, China
Full record on ClinicalTrials.gov
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