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NCT Number: NCT07177742

Prospective Cohort Study on the Relationship Between Exosomal Peroxiredoxin 1 (PRDX1) and Postoperative Liver Metastasis

The occurrence of liver metastasis after curative surgery for resectable colorectal cancer is an important cause of death for patients. Accurately identifying high-risk patients for metastasis and intervening in them has important clinical significance. The pathological examination of surgical specimens failed to fully utilize valuable specimen information and accurately predict liver metastasis; The biomarkers secreted by tumors are metabolized in the liver through the portal vein, especially the particles such as extracellular vesicles secreted by tumors, which are ultimately diluted in peripheral blood and cannot be effectively detected. Our research group extracted an average of 11.25ml of blood (named blood derived from portal vein branch specimens, sdBlood for short) from 8 colorectal cancer radical surgery specimens. Compared with peripheral blood, protein mass spectrometry analysis revealed a significant increase in exosome proteins such as peroxidized redox protein 1 (PRDX1), which are highly correlated with metastasis. This project innovatively uses sdBlood, which has been overlooked by routine pathological examination, to detect the exosomal protein PRDX1 in sdBlood, which is significantly higher than the peripheral blood concentration. A prospective cohort study was established, including 252 patients with pathologically confirmed colorectal cancer after radical surgery. The incidence and time of liver metastasis were followed up and observed. Cox regression statistical analysis was used to determine the correlation between this marker and metastasis and determine its critical value, providing a basis for clinical diagnosis and treatment.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Exosome Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Metastases From Colorectal Cancer Neoplasms Neoplasms by Site Pathology Peroxidized Redox Protein 1 Rectal Diseases

Age range

19 month–80 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Tongji Hospital, Hepatobilliary Surgery Center, Tongji University

Shanghai, Shanghai Municipality, 200065, China

Location status: Recruiting

Location contact

Muqing Yang

CONTACT

[email protected]

+8615221817051

Muqing Yang, Doctor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

observation

Other

Observation.

Primary outcomes

  1. Liver metastasis.

    Time frame: From enrollment to 5 years after coloretal radical surgery.

    During the follow-up period, the study subjects exhibited liver metastatic lesions (at least on nodal with enhanced and diameter over 1 cm, or diameter over 0.5cm with increased diameter during consecutive two followups) on imaging examinations (enhanced abdominal CT, enhanced MRI, or 18FDP-PET scan), which were confirmed as liver metastasis after interpretation by a deputy chief surgeon and a physician with a position higher than deputy chief in radiology.

Secondary outcomes

  1. Local recurrence.

    Time frame: From enrollment to 5 years after colorectal radical resection.

    During the follow-up period, the study subjects exhibited local lesions over 1cm on imaging examinations (enhanced abdominal CT, enhanced MRI, or 18FDP-PET scan), which were confirmed as liver metastasis after interpretation by a deputy chief surgeon and a physician with a position higher than deputy chief in radiology. During the follow-up period, the study subjects exhibited liver metastatic lesions on imaging examinations (enhanced abdominal CT, enhanced MRI, or 18FDP-PET scan), which were confirmed as local recurrence after interpretation by a deputy chief surgeon and a physician with a position higher than deputy chief in radiology.

  2. Lung metastasis.

    Time frame: From enrollment to 5 years after colorectal radical resection.

    During the follow-up period, the study subjects exhibited new lesions (at least on nodal with enhanced and diameter over 1 cm, or diameter over 0.5cm with increased diameter during consecutive two followups) on imaging examinations (chest plain CT, or 18FDP-PET scan), which were confirmed as lung metastasis after interpretation by a deputy chief surgeon and a physician with a position higher than deputy chief in radiology.

  3. Peritoneal recurrence.

    Time frame: From enrollment to 5 years after colorectal radical resection.

    During the follow-up period, the study subjects exhibited new peritoneal lesions (at least on nodal with enhanced and diameter over 1 cm, or diameter over 0.5cm with increased diameter during consecutive two followups) on imaging examinations (enhanced abdominal CT, enhanced MRI, or 18FDP-PET scan), which were confirmed as peritoneal metastasis after interpretation by a deputy chief surgeon and a physician with a position higher than deputy chief in radiology.

Sponsors and collaborators

Lead sponsor

Mu-qing Yang

Other

Registry information

Official study title

Prospective Cohort Study on the Relationship Between Peroxiredoxin 1 (PRDX1) in Blood Exosomes From Colorectal Cancer Radical Resection Specimens and Postoperative Liver Metastasis

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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