Status:
NOT_YET_RECRUITING
Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Intestinal Carcinoma
Lead Sponsor:
Xijing Hospital
Conditions:
Intestinal Cancer
Eligibility:
All Genders
18-75 years
Brief Summary
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-enhan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06979882
Start Date
May 25 2025
End Date
March 1 2030
Last Update
May 20 2025
Active Locations (2)
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1
Tangdu Hospital
Xi'an, Shaanxi, China
2
Xijing Hospital
Xi'an, Shaanxi, China