Link between tumor exosomal PRDX1 in portal-vein blood and post-surgery liver metastasis
Prospective Cohort Study on the Relationship Between Peroxiredoxin 1 (PRDX1) in Blood Exosomes From Colorectal Cancer Radical Resection Specimens and Postoperative Liver Metastasis
This study will test whether levels of exosomal PRDX1 measured in blood taken from the portal/mesenteric vein during colorectal cancer surgery can help predict who will develop liver metastases after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 19 Months to 80 Months |
| Sex | All |
| Sponsor | Shanghai Tongji Hospital, Tongji University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07177742 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort where blood will be collected from a branch of the portal/mesenteric vein at the time of curative colorectal cancer resection and exosomes will be isolated for protein analysis focused on PRDX1. Protein mass spectrometry or targeted assays will quantify exosomal PRDX1 and compare portal-derived levels with peripheral measures. Patients will be followed after surgery for development of liver metastasis and results will be correlated with the measured biomarker levels. The team reports preliminary data showing higher PRDX1 in portal-vein–derived blood than in peripheral blood, and the protocol excludes patients with preexisting liver disease, prior anti-tumor therapy, or inability to provide intraoperative portal blood.
Who should consider this trial
Good fit: Adults aged 19–80 with pathologically confirmed colon adenocarcinoma who undergo and complete radical colorectal resection and consent to intraoperative portal/mesenteric vein blood collection are the intended participants.
Not a fit: Patients who had prior neoadjuvant therapy, have significant preexisting liver disease, require combined organ resection, or from whom portal-vein blood cannot be obtained are unlikely to benefit from the marker measured here.
Why it matters
Potential benefit: If successful, this approach could identify patients at higher risk of liver metastasis so they can receive closer surveillance or tailored adjuvant treatment sooner.
How similar studies have performed: Other groups have shown that tumor-derived exosomal markers can correlate with metastatic risk in cancers, but using portal-vein–derived exosomes and PRDX1 specifically is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age between 19-80 years old, gender not limited;
* Can comply with the requirements of the research visit plan and other protocols;
* Voluntarily participate and sign an informed consent form; ④ Diagnosed with colon adenocarcinoma through pathological examination; ⑤ Patients who have completed colorectal radical surgery.
Exclusion Criteria:
* Patients who cannot complete radical surgery for colorectal cancer;
* Patients with liver diseases (chronic hepatitis B, hepatitis C, severe fatty liver, cirrhosis);
* Patients who require combined organ resection;
* Combine patients with other malignant tumors or blood or immune system diseases; ⑤ Prior to tumor resection, any anti-tumor treatment, including radiotherapy, chemotherapy, and molecular targeted therapy, has been performed; ⑥ After surgery, it was found that the mesenteric vein branch of the specimen could not obtain blood due to severe infiltration or other reasons.
* Patients with severe postoperative complications leading to delayed treatment (Clavien-Dindo grade III or above).
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Tongji Hospital, Hepatobilliary Surgery Center, Tongji University — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.