NCT06979882Not yet recruitingNot Applicable
Investigating Multigene Methylation Dynamics in Treatment Response Surveillance for Intestinal Carcinoma
Xijing Hospital2 sites in 1 country200 target enrollmentStarted: May 25, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Multi-gene methylation levels
Study Overview
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-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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Multi-gene methylation levels
Time Frame: Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.
Secondary Outcomes
- Tumor Markers (including CEA, AFP, CA125, CA19-9, CA72-4, etc.)(Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.)
- Endoscope(Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.)
- Imaging Examinations (including contrast-enhanced CT, PET/CT, ultrasound, X-ray, magnetic resonance imaging, etc.)(Group three: pre-neoadjuvant therapy baseline, 1 week following neoadjuvant therapy, and post-neoadjuvant therapy at 1 month, 3 months, 6 months, 1 year, 18 months (1.5 years), 2 years, 3 years, 4 years, and 5 years.)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Epigenetics, DNA Methylation Patterns and Periodontal DiseasePeriodontal DiseaseNCT01399034University of North Carolina, Chapel Hill98
Recruiting
Not Applicable
Specific Methylation Profiles in HNSCCHead and Neck Squamous Cell CarcinomaNCT04567056Aalborg University Hospital300
Unknown
Not Applicable
Multi Institutional Study in Patient Presenting With HematuriaHematuriaBladder CancerNCT03122964MDx Health1,148
Completed
Not Applicable
Biomarkers in Predicting Response to Chemotherapy in Samples From Young Patients With OsteosarcomaLocalized OsteosarcomaOsteoblastic OsteosarcomaRecurrent OsteosarcomaMetastatic OsteosarcomaNCT01374672Children's Oncology Group20
Recruiting
Not Applicable
INSPIRE: a Multi-Cancer Early Detection StudyEndometrial CancerCholangiocarcinomaBreast CancerProstate CancerColorectal CancerLung CancerOvarian CancerPancreatic CancerGastric CancerCervical CancerBladder CancerEsophageal CancerLiver CancerNCT06440018Singlera Genomics Inc.5,350