Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Intestinal Carcinoma

NCT ID: NCT06979882

Last Updated: 2025-05-20

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

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-25

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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Intestinal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group one

Intestinal 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

Intestinal 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

Intestinal 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

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

Eligibility Criteria

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Inclusion Criteria

Age at initial diagnosis: 18-75 years Histologically confirmed colorectal or small intestinal 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

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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Tangdu Hospital

Xi'an, Shaanxi, China

Site Status

Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Central Contacts

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Zhongyang Zhang

Role: CONTACT

+86 18831363219

Facility Contacts

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Xianchun Gao, doctor

Role: primary

+86 18165302960

Zhongyang Zhang

Role: primary

+86 188 3136 3219

Other Identifiers

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KY20252140-F-1

Identifier Type: -

Identifier Source: org_study_id

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