Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Gastric Cancer

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-25

Study Completion Date

2030-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DNA Methylation Biomarkers and Metastasis of Gastric Carcinoma

NCT02159339

Gastric Carcinoma

COMPLETED

Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Gastric Cancer：MetBio-GC

NCT07076979

Gastric Cancer

RECRUITING

Development of Free DNA Multi-target Methylated PCR for Auxiliary Diagnosis of Gastric Cancer

NCT05336058

Stomach Cancer

COMPLETED

Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA

NCT05668910

Gastric Cancer

UNKNOWN

Cell-free DNA Methylation Markers for Cancer Screening

NCT03096938

Cancer Screening

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric (Stomach) Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group one

Gastric 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

Gastric cancer patients undergoing surgery following neoadjuvant therapy

Multi-gene methylation testing

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Age at initial diagnosis: 18-75 years Histologically confirmed gastric or gastroesophageal junction malignancy, with complete medical records, confirmed pathological diagnosis, and definitive staging data (TNM staging system) No history of other primary malignancies Absence of distant metastases (liver, lung, or other sites) confirmed by imaging examination (CT/MRI) No prior surgical resection, chemotherapy, or PD-1/PD-L1 immunotherapy before enrollment Availability of complete biospecimen information, including: Sample ID (medical record number), Demographic data (sex, age), Clinical diagnostic data, Tumor marker profiles (CEA, CA19-9, etc.)

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