Actively Recruiting
Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma
Led by Xijing Hospital · Updated on 2025-12-16
300
Participants Needed
9
Research Sites
248 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at initial diagnosis: 18-75 years (inclusive)
- Histologically proven esophageal carcinoma with complete medical records
- Definitive pathological diagnosis report available
- TNM staging according to AJCC 8th edition criteria
- No prior malignancies at other anatomical sites except cured non-melanoma skin cancers or carcinoma in situ
- No distant metastases in liver, lungs, or other organs confirmed by contrast-enhanced CT/MRI and whole-body bone scan within 4 weeks before enrollment
- No previous esophageal resection surgery
- No prior systemic chemotherapy
- No prior thoracic radiation therapy over 10 Gy
- No prior treatment with PD-1/PD-L1 immune checkpoint inhibitors
You will not qualify if you...
- Life expectancy less than 6 months (ECOG score 4 or Palliative Performance Scale 30% or less)
- Legally incapacitated individuals without legal guardians
- Active psychotic disorders such as schizophrenia or bipolar disorder
- Dementia with MMSE score less than 24
- Other exclusions determined by the investigator
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Gansu Wuwei Cancer Hospital
Wuwei, Gansu, China
Actively Recruiting
2
Cancer Hospital Affiliated to Shantou University Medical College
Shantou, Guangdong, China
Not Yet Recruiting
3
Zhaoqing Gaoyao District People's Hospital
Zhaoqing, Guangdong, China
Actively Recruiting
4
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
5
Tangdu Hospital
Xi'an, Shaanxi, China
Not Yet Recruiting
6
Xijing Hospital
Xi'an, Shaanxi, China
Actively Recruiting
7
The First Affiliated Hospital of Yan'an University
Yan’an, Shaanxi, China
Not Yet Recruiting
8
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Not Yet Recruiting
9
General Hospital of Western Theater Command, People's Liberation Army (PLA)
Chengdu, Sichuan, China
Actively Recruiting
Research Team
Z
Zhongyang Zhang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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