Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma

A

Air Force Military Medical University of People's Liberation Army

Status

Enrolling

Conditions

Esophageal Cancer

Treatments

Other: Multi-gene methylation testing

Study type

Observational

Funder types

Other

Identifiers

NCT06979869

KY20252117-F-1

Details and patient eligibility

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

300 participants in 4 patient groups

Group one

Description:

Esophageal cancer patients undergoing primary surgical treatment

Treatment:

Other: Multi-gene methylation testing

Group two

Description:

Esophageal cancer patients undergoing surgery following neoadjuvant therapy

Treatment:

Other: Multi-gene methylation testing

Group three

Description:

Esophageal cancer patients undergoing active surveillance following neoadjuvant therapy

Treatment:

Other: Multi-gene methylation testing

Group four

Description:

Esophageal cancer patients undergoing definitive chemoradiotherapy with or without immunotherapy

Treatment:

Other: Multi-gene methylation testing

Trial contacts and locations

9

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Central trial contact

Zhongyang Zhang