Clinical trial · Observational
Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Intestinal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intestinal Cancer | Malignant Intestinal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-gene methylation testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Group one
- description
- Intestinal cancer patients undergoing primary surgical treatment
- interventionNames
- Other: Multi-gene methylation testing
- label
- Group two
- description
- Intestinal cancer patients undergoing surgery following neoadjuvant therapy
- interventionNames
- Other: Multi-gene methylation testing
- label
- Group three
- description
- Intestinal cancer patients undergoing active surveillance following neoadjuvant therapy
- interventionNames
- Other: Multi-gene methylation testing
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available