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Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Intestinal Carcinoma

A

Air Force Military Medical University of People's Liberation Army

Status

Not yet enrolling

Conditions

Intestinal Cancer

Treatments

Other: Multi-gene methylation testing

Study type

Observational

Funder types

Other

Identifiers

NCT06979882
KY20252140-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

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

Group one
Description:
Intestinal cancer patients undergoing primary surgical treatment
Treatment:
Other: Multi-gene methylation testing
Other: Multi-gene methylation testing
Other: Multi-gene methylation testing
Group two
Description:
Intestinal cancer patients undergoing surgery following neoadjuvant therapy
Treatment:
Other: Multi-gene methylation testing
Other: Multi-gene methylation testing
Other: Multi-gene methylation testing
Group three
Description:
Intestinal cancer patients undergoing active surveillance following neoadjuvant therapy
Treatment:
Other: Multi-gene methylation testing
Other: Multi-gene methylation testing
Other: Multi-gene methylation testing

Trial contacts and locations

2

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Central trial contact

Zhongyang Zhang

Data sourced from clinicaltrials.gov

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