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Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Esophageal Carcinoma

NCT ID: NCT06979869

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-26

Study Completion Date

2030-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group one

Esophageal cancer patients undergoing primary surgical treatment

Multi-gene methylation testing

Intervention Type OTHER

Undergo multi-gene methylation testing in blood during follow-up

Group two

Esophageal cancer patients undergoing surgery following neoadjuvant therapy

Multi-gene methylation testing

Intervention Type OTHER

Undergo multi-gene methylation testing in blood during follow-up

Group three

Esophageal cancer patients undergoing active surveillance following neoadjuvant therapy

Multi-gene methylation testing

Intervention Type OTHER

Undergo multi-gene methylation testing in blood during follow-up

Group four

Esophageal cancer patients undergoing definitive chemoradiotherapy with or without immunotherapy

Multi-gene methylation testing

Intervention Type OTHER

Undergo multi-gene methylation testing in blood during follow-up

Interventions

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Multi-gene methylation testing

Undergo multi-gene methylation testing in blood during follow-up

Intervention Type OTHER

Multi-gene methylation testing

Undergo multi-gene methylation testing in blood during follow-up

Intervention Type OTHER

Multi-gene methylation testing

Undergo multi-gene methylation testing in blood during follow-up

Intervention Type OTHER

Multi-gene methylation testing

Undergo multi-gene methylation testing in blood during follow-up

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gansu Wuwei Cancer Hospital

Wuwei, Gansu, China

Site Status RECRUITING

Cancer Hospital Affiliated to Shantou University Medical College

Shantou, Guangdong, China

Site Status NOT_YET_RECRUITING

Zhaoqing Gaoyao District People's Hospital

Zhaoqing, Guangdong, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Tangdu Hospital

Xi'an, Shaanxi, China

Site Status NOT_YET_RECRUITING

Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

The First Affiliated Hospital of Yan'an University

Yan’an, Shaanxi, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status NOT_YET_RECRUITING

General Hospital of Western Theater Command, People's Liberation Army (PLA)

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhongyang Zhang

Role: CONTACT

[email protected]
+86 188 3136 3219

Facility Contacts

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Sitian Dai

Role: primary

[email protected]
+86 19567636380

Jialu Jiang

Role: primary

[email protected]
+86 18354692937

Xianchun Gao

Role: primary

[email protected]
+86 18165302960

Abudurousuli Reyila

Role: primary

[email protected]
+86 15254166320

Xianchun Gao, doctor

Role: primary

[email protected]
+86 18165302960

Zhongyang Zhang

Role: primary

[email protected]
+86 188 3136 3219

Jun Yu

Role: primary

[email protected]
+86 15872427852

Yan Pan

Role: primary

[email protected]
+86 13484660214

Rong Zheng

Role: primary

[email protected]
19829758242

Other Identifiers

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KY20252117-F-1

Identifier Type: -

Identifier Source: org_study_id