Multi-gene methylation testing: Undergo multi-gene methylation testing in blood during follow-up
Multi-gene methylation testing: Undergo multi-gene methylation testing in blood during follow-up
Multi-gene methylation testing: Undergo multi-gene methylation testing in blood during follow-up
Multi-gene methylation testing: Undergo multi-gene methylation testing in blood during follow-up
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Multi-gene methylation levels — Group one: Preoperative, 1 week, 1 month, 3 months, 6 months, 1 year, 1.5 years, 2 years, 3 years, 4 years, and 5 years postoperatively.
Multi-gene methylation levels — Group two: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and postoperatively at 1 week, 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.
Multi-gene methylation levels — Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.
Multi-gene methylation levels — Group four: pre-definitive chemoradiotherapy baseline, and post-definitive chemoradiotherapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.
Trial sites (9)
Facility
City
Region
Status
Gansu Wuwei Cancer Hospital
Wuwei
Gansu
Recruiting
Cancer Hospital Affiliated to Shantou University Medical College
Shantou
Guangdong
Not Yet Recruiting
Zhaoqing Gaoyao District People's Hospital
Zhaoqing
Guangdong
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
Tangdu Hospital
Xi'an
Shaanxi
Not Yet Recruiting
Xijing Hospital
Xi'an
Shaanxi
Recruiting
The First Affiliated Hospital of Yan'an University
Yan’an
Shaanxi
Not Yet Recruiting
The First Affiliated Hospital of Shanxi Medical University
Taiyuan
Shanxi
Not Yet Recruiting
General Hospital of Western Theater Command, People's Liberation Army (PLA)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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