A Predictive Model for Recurrence of Colorectal Cancer Based on Multi-omics of Portal Vein Blood
PVMRD
1 other identifier
observational
350
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 23, 2024
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 31, 2024
July 1, 2024
6.9 years
July 23, 2024
July 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colorectal Cancer Recurrence or Metastasis
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.
24 months post-surgery
Secondary Outcomes (1)
Overall Survival
24 months post-surgery
Study Arms (1)
CRC Patients - Curative Surgery
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Prior history of other malignancies
- Incomplete clinical information or pathology reports
- Incomplete follow-up records
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking University Shougang Hospitallead
- Beijing Tiantan Hospitalcollaborator
- Peking University Third Hospitalcollaborator
- Peking University First Hospitalcollaborator
- Chinese PLA General Hospitalcollaborator
Study Sites (1)
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144, China
Biospecimen
This study will retain various biospecimens for multi-omics analysis. Specifically, we will collect peripheral blood, portal vein blood, and tissue samples from patients. Peripheral blood samples will be collected pre-operatively, approximately 10 mL in cfDNA-specific collection tubes, processed to separate plasma, and stored at -80°C for DNA, RNA, and protein analyses. Portal vein blood samples will be collected during surgery in the same manner (Detailed method was written in the study description), ensuring high tumor-derived biomarker concentration.Tissue samples, including primary tumor, adjacent tissue, and normal intestinal tissue, will be collected after surgery. These samples will be stored at -80°C.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin Gu, Prof.
Peking University Shougang Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2024
First Posted
July 29, 2024
Study Start
January 1, 2020
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 31, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share
Who can access the data: Researchers whose proposed use of the data has been approved Data types: Deidentified participant data How to access data: The data that support the findings of this study are available from the corresponding author (zlguj@bjmu.edu.cn) upon reasonable request. When available: With publication