Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma
1 other identifier
observational
300
1 country
9
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-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2025
CompletedFirst Posted
Study publicly available on registry
May 20, 2025
CompletedStudy Start
First participant enrolled
May 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
December 16, 2025
May 1, 2025
4.8 years
April 23, 2025
December 14, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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.
Secondary Outcomes (12)
Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.)
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.
Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.)
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.
Endoscope
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.
Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.)
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.
Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.)
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.
- +7 more secondary outcomes
Study Arms (4)
Group one
Esophageal cancer patients undergoing primary surgical treatment
Group two
Esophageal cancer patients undergoing surgery following neoadjuvant therapy
Group three
Esophageal cancer patients undergoing active surveillance following neoadjuvant therapy
Group four
Esophageal cancer patients undergoing definitive chemoradiotherapy with or without immunotherapy
Interventions
Undergo multi-gene methylation testing in blood during follow-up
Eligibility Criteria
Esophageal cancer patients
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (9)
Gansu Wuwei Cancer Hospital
Wuwei, Gansu, China
Cancer Hospital Affiliated to Shantou University Medical College
Shantou, Guangdong, China
Zhaoqing Gaoyao District People's Hospital
Zhaoqing, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tangdu Hospital
Xi'an, Shaanxi, China
Xijing Hospital
Xi'an, Shaanxi, China
The First Affiliated Hospital of Yan'an University
Yan’an, Shaanxi, China
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
General Hospital of Western Theater Command, People's Liberation Army (PLA)
Chengdu, Sichuan, China
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2025
First Posted
May 20, 2025
Study Start
May 26, 2025
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
March 1, 2030
Last Updated
December 16, 2025
Record last verified: 2025-05