Clinical trial NCT06979869: Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma
Official title: Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Esophageal Cancer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Esophageal cancer patients

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.


Eligibility criteria: 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 outcomes:
measure: Multi-gene methylation levels
timeFrame: 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.
measure: Multi-gene methylation levels
timeFrame: 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.
measure: Multi-gene methylation levels
timeFrame: 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.
measure: Multi-gene methylation levels
timeFrame: 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:
measure: Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.)
timeFrame: 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.
measure: Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.)
timeFrame: 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.
measure: Endoscope
timeFrame: 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.
measure: Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.)
timeFrame: 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.
measure: Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.)
timeFrame: 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.
measure: Endoscope
timeFrame: 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.
measure: Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.)
timeFrame: 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.
measure: Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.)
timeFrame: 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.
measure: Endoscope
timeFrame: 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.
measure: Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.)
timeFrame: 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.
measure: Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.)
timeFrame: 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.
measure: Endoscope
timeFrame: 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.
Other outcomes:
Locations:
city: Wuwei city
country: China
facility: Gansu Wuwei Cancer Hospital
state: Gansu
city: Shantou city
country: China
facility: Cancer Hospital Affiliated to Shantou University Medical College
state: Guangdong
city: Zhaoqing city
country: China
facility: Zhaoqing Gaoyao District People's Hospital
state: Guangdong
city: Zhengzhou city
country: China
facility: Henan Cancer Hospital
state: Henan
city: Xi'an City
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Xi'an City
country: China
facility: Xijing Hospital
state: Shaanxi
city: Yan'an city
country: China
facility: The First Affiliated Hospital of Yan'an University
state: Shaanxi
city: Taiyuan city
country: China
facility: The First Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu city
country: China
facility: General Hospital of Western Theater Command, People's Liberation Army (PLA)
state: Sichuan
Study officials:
References: