Colorectal CancerNCT07177742
Prospective Cohort Study on the Relationship Between Exosomal Peroxiredoxin 1 (PRDX1) and Postoperative Liver Metastasis
An observational study of Colorectal Cancer and Liver Metastases From Colorectal Cancer, run by Mu-qing Yang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 80 months
- Conditions the study is for
- Colorectal Cancer, Liver Metastases From Colorectal Cancer, Pathology
- What is being tested?
- Observation
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2021to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 months
- All sexes
- No healthy volunteers
- Child
Study population: Local resectable colorectal cancer patients aged 19-80 years who have not undergone preoperative radiotherapy or chemotherapy and have no distant metastasis.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Tongji Hospital, Hepatobilliary Surgery Center, Tongji University
Shanghai, Shanghai Municipality, 200065
Muqing Yang, +8615221817051, andyymq@foxmail.com
Muqing Yang, Doctor
About this study
Official title: Prospective Cohort Study on the Relationship Between Peroxiredoxin 1 (PRDX1) in Blood Exosomes From Colorectal Cancer Radical Resection Specimens 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.
- Conditions
- Colorectal Cancer, Liver Metastases From Colorectal Cancer, Pathology, Exosome, Peroxidized Redox Protein 1
- Being tested
- Observation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation.
| Study group | Role | What they receive |
|---|---|---|
| A surgical resectable colorectal cancer patients are set as prospective cohort. | The blood obtained from surgical resection specimens of resectable colorectal cancer patients was used to extract their serum exosomes and detect the concentration of PRDX1. The patients were aged 19-80 years and were planned to be included in a prospective follow-up cohort of 252. The occurrence of metastasis was observed, and the predicted and critical values of PRDX1 concentration in portal vein branch serum exosomes obtained from the specimens were analyzed. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver metastasis.
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.
Measured: From enrollment to 5 years after coloretal radical surgery.
Secondary outcomes (3)
Local recurrence.
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.
Measured: From enrollment to 5 years after colorectal radical resection.
Lung metastasis.
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.
Measured: From enrollment to 5 years after colorectal radical resection.
Peritoneal recurrence.
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.
Measured: From enrollment to 5 years after colorectal radical resection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start15 Feb 2021
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mu-qing Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mu-qing Yang, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177742
- Sponsor's protocol ID
- K-2024-017
- Status last verified
- Feb 2026
- First submitted
- 10 Sep 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on the Relationship Between Peroxiredoxin 1 (PRDX1) in Blood Exosomes From Colorectal Cancer Radical Resection Specimens and Postoperative Liver Metastasis
- ClinicalTrials.gov ID
- NCT07177742
- Acronym / sponsor ID
- K-2024-017
- Conditions
- Colorectal Cancer, Liver Metastases From Colorectal Cancer, Pathology, Exosome, Peroxidized Redox Protein 1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Mu-qing YangUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A surgical resectable colorectal cancer patients are set as prospective cohort. | – | Other: ObservationThe blood obtained from surgical resection specimens of resectable colorectal cancer patients was used to extract their serum exosomes and detect the concentration of PRDX1. The patients were aged 19-80 years and were planned to be included in a prospective follow-up cohort of 252. The occurrence of metastasis was observed, and the predicted and critical values of PRDX1 concentration in portal vein branch serum exosomes obtained from the specimens were analyzed. |
Who may qualify
- Ages
- 19 to 80 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Local resectable colorectal cancer patients aged 19-80 years who have not undergone preoperative radiotherapy or chemotherapy and have no distant metastasis.
Key inclusion criteria (3 listed)
- Age between 19-80 years old, gender not limited;
Key exclusion criteria (5 listed)
- Patients who cannot complete radical surgery for colorectal cancer;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObservation. | Other | A surgical resectable colorectal cancer patients are set as prospective cohort. |
Primary outcome
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.
3 secondary outcomes
Local recurrence.
Time frame: From enrollment to 5 years after colorectal radical resection.
Lung metastasis.
Time frame: From enrollment to 5 years after colorectal radical resection.
Peritoneal recurrence.
Time frame: From enrollment to 5 years after colorectal radical resection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Colorectal Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 1
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Phase 1, SAR445877
Recruiting
Addressing Disparities in Colorectal Cancer Screening in Black and Underserved Phoenix Communities
Colorectal Carcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruiting
Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas
Colorectal Cancer (CRC) Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shanghai Tongji Hospital, Hepatobilliary Surgery Center, Tongji University
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Liver Metastases From Colorectal Cancer, run by Mu-qing Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver metastasis. (time frame: From enrollment to 5 years after coloretal radical surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.