Status:
RECRUITING
Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma
Lead Sponsor:
Xijing Hospital
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-75 years
Brief 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-enhan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06979869
Start Date
May 26 2025
End Date
March 1 2030
Last Update
December 16 2025
Active Locations (9)
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1
Gansu Wuwei Cancer Hospital
Wuwei, Gansu, China
2
Cancer Hospital Affiliated to Shantou University Medical College
Shantou, Guangdong, China
3
Zhaoqing Gaoyao District People's Hospital
Zhaoqing, Guangdong, China
4
Henan Cancer Hospital
Zhengzhou, Henan, China