Clinical trial · Observational
A Predictive Model for Recurrence of Colorectal Cancer Based on Multi-omics of Portal Vein Blood
A Predictive Model for Recurrence of Colorectal Cancer Based on Multi-omics of Portal Vein Blood: a Multi-center Study
- 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)
This multi-center study aims to develop a precise predictive model for colorectal cancer (CRC) recurrence and metastasis based on multi-omics analysis of portal vein blood. Despite advances in surgical treatments, approximately 40% of CRC patients experience tumor recurrence or metastasis post-surgery, with 80-90% of metastases being unresectable. The study will include stage I-IV CRC patients and will be conducted in two phases: a nested case-control study and a bidirectional cohort study. Comprehensive multi-omics sequencing will be performed on samples from primary tumors, adjacent tissues, normal intestinal tissues, portal vein blood, and peripheral blood. The goal is to identify specific biomarkers in the portal vein and peripheral blood associated with CRC recurrence and metastasis, and to compare the predictive accuracy of models based on these biomarkers. The ultimate objective is to provide a more effective method for early prediction and intervention of CRC recurrence and metastasis, thereby improving patient outcomes. Project Information: Project Title: A predictive model for recurrence of colorectal cancer based on multi-omics of portal vein blood: a multi-center study Project Duration: January 2020 to December 2026 Lead Institution: Peking University Shougang Hospital Principal Investigator: Gu Jin Contact: Hong Haopeng, 18059211195@163.com
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- CRC Patients - Curative Surgery
- description
- This cohort includes patients diagnosed with stage I-IV colorectal cancer (CRC) who have undergone curative surgery. Inclusion criteria: patients aged 18 years or older, histologically confirmed CRC, no prior history of malignancy, availability of pre-operative and intra-operative blood samples (portal vein and peripheral blood), and primary tumor tissue samples. Patients must not have received neoadjuvant therapy before surgery and must have complete follow-up data. Exclusion criteria: prior history of other malignancies, incomplete clinical information or pathology reports, and incomplete follow-up records. The study aims to identify specific biomarkers associated with CRC recurrence and metastasis through comprehensive multi-omics sequencing and develop predictive models for CRC recurrence and metastasis.
Primary outcomes (1)
- measure
- Colorectal Cancer Recurrence or Metastasis
- timeFrame
- 24 months post-surgery
- description
- The primary outcome measure is the occurrence of colorectal cancer (CRC) recurrence or metastasis within 24 months post-surgery. This will be monitored through clinical evaluations, imaging studies (CT, MRI), and blood tests (CEA levels). Recurrence or metastasis will be defined by persistent elevation in CEA, and/or detection of local recurrence or distant metastases through imaging and biopsy confirmation.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Histologically confirmed stage I-IV colorectal cancer (CRC) * Availability of pre-operative and intra-operative blood samples (portal vein and peripheral blood) and primary tumor tissue samples * No neoadjuvant therapy before surgery Exclusion Criteria: * Prior history of other malignancies * Incomplete clinical information or pathology reports * Incomplete follow-up records
References
Publications (0)
Data not yet available