Colorectal Cancer (CRC)NCT06904677
Using 4D Urinary Proteomics to Predict and Evaluate Treatment Response in Colorectal Cancer
An observational study of Colorectal Cancer (CRC) and Neoadjuvant Therapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The goal of this observational study is to learn how well urinary proteins can predict treatment response in patients with locally advanced colorectal cancer (LACC) undergoing neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer (CRC), Neoadjuvant Therapy, Proteomics
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 May 2029
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll patients aged 18 to 75 years with a pathologically confirmed diagnosis of locally advanced colorectal cancer (LACC), defined as clinical stage cT3-4 and/or N+ without distant metastasis (M0) as determined by imaging (CT and/or PET-CT). Eligible participants must be treatment-naïve, with no prior exposure to anti-tumor therapies such as chemotherapy, targeted therapy, or immunotherapy. All patients must be clinically assessed as suitable candidates for neoadjuvant therapy followed by surgical resection and must be able to tolerate and complete the prescribed treatment regimen. In addition, participants must be willing and able to provide urine samples before and after neoadjuvant therapy and must sign written informed consent prior to enrollment. Patients will be excluded if they have a history of or concurrent diagnosis of other malignancies; suffer from serious hepatic, renal, cardiovascular, or metabolic conditions that may interfere with urinary protein metab
Who may be able to join
- Aged 18-75 years;
- Pathologically confirmed diagnosis of locally advanced colorectal cancer (cT3-4 and/or N+);
- Planned to undergo neoadjuvant therapy followed by surgical resection;
- No evidence of distant metastasis (M0) confirmed by imaging (CT and/or PET-CT);
- Clinically assessed as being able to tolerate and complete the full course of neoadjuvant treatment;
- No prior anti-tumor therapy (e.g., targeted therapy, immunotherapy) before the initiation of treatment;
- Willing and able to provide urine samples as required;
- Written informed consent obtained.
Who cannot join
- History of or concurrent diagnosis with other malignancies;
- Presence of severe hepatic, renal, cardiovascular, or metabolic diseases that may affect urinary protein metabolism;
- Recent use of medications known to affect protein metabolism (e.g., glucocorticoids, high-dose antibiotics);
- Urinary tract infection or other diseases known to cause abnormal urinary protein levels (e.g., nephrotic syndrome);
- Any other condition deemed unsuitable for enrollment by the investigators.
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
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Chaoyang District, 100021
Qian Liu, M.D., 13601008906, fcwpumch@163.com
Qian Liu, M.D.
About this study
Official title: Predicting and Evaluating the Efficacy of Neoadjuvant Therapy in Colorectal Cancer Based on 4D Deep Urinary Proteomics Technology
The goal of this observational study is to learn how well urinary proteins can predict treatment response in patients with locally advanced colorectal cancer (LACC) undergoing neoadjuvant therapy. The main question it aims to answer is:
Can urinary protein markers help predict and evaluate how patients with LACC respond to neoadjuvant therapy?
Participants diagnosed with LACC will provide urine samples before and after neoadjuvant therapy. These samples will be analyzed using 4D deep urinary proteomics and machine learning to identify proteins linked to treatment response. Some participants' tumor tissues will also be used to create organoid models for further testing.
Read the detailed description
Neoadjuvant therapy is one of the main treatment strategies for patients with locally advanced colorectal cancer (LACC). However, the response to neoadjuvant therapy varies greatly among individuals, presenting a significant clinical challenge in accurately predicting therapeutic efficacy before treatment and dynamically assessing response during therapy. Commonly used clinical methods-such as imaging techniques, tissue biomarkers, and liquid biomarkers-often suffer from low sensitivity and specificity.
In our previous research, we applied 4D deep urinary proteomics to analyze pre-treatment urine samples from patients classified as responders and non-responders to neoadjuvant therapy. The results demonstrated that urinary proteomic profiles reflect differences in the tumor microenvironment associated with treatment response and hold promise for predicting therapeutic efficacy.
Building on this foundation, the current project aims to optimize the 4D deep urinary proteomics workflow and perform comparative analyses of urine samples collected before and after neoadjuvant therapy. Machine learning algorithms will be employed to identify candidate urinary proteins associated with treatment response, and key proteins will be validated using targeted proteomics and immunological techniques. Additionally, patient-derived organoid (PDO) models will be used to explore the biological functions of candidate proteins and elucidate their roles in mediating sensitivity to neoadjuvant therapy.
This study is expected to enable precise stratification of LACC patients and support the implementation of personalized treatment strategies. Furthermore, it may uncover mechanisms of resistance and propose novel therapeutic approaches to improve clinical decision-making and outcomes.
- Conditions
- Colorectal Cancer (CRC), Neoadjuvant Therapy, Proteomics
- Keywords
- Colorectal caner, Neoadjuvant therapy, Urinary proteomics
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| nCRT group | Diagnosed with rectal cancer and receiving neoadjuvant chemoradiotherapy. | |
| chemotherapy group | Diagnosed with colorectal cancer and receiving neoadjuvant chemoradiotherapy. | |
| immunochemotherapy group | Diagnosed with colorectal cancer and receiving neoadjuvant immunochemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor regression grade
Tumor regression after neoadjuvant therapy (based on pathological analysis of the resected specimen)
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, QIAN LIU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904677
- Sponsor's protocol ID
- NCC2025C-464
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to concerns regarding patient privacy and confidentiality, as well as institutional regulations on data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting and Evaluating the Efficacy of Neoadjuvant Therapy in Colorectal Cancer Based on 4D Deep Urinary Proteomics Technology
- ClinicalTrials.gov ID
- NCT06904677
- Acronym / sponsor ID
- NCC2025C-464
- Conditions
- Colorectal Cancer (CRC), Neoadjuvant Therapy, Proteomics
- Keywords
- Colorectal caner, Neoadjuvant therapy, Urinary proteomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 1 Apr 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 goal of this observational study is to learn how well urinary proteins can predict treatment response in patients with locally advanced colorectal cancer (LACC) undergoing neoadjuvant therapy. The main question it aims to answer is:
Can urinary protein markers help predict and evaluate how patients with LACC respond to neoadjuvant therapy?
Participants diagnosed with LACC will provide urine samples before and after neoadjuvant therapy. These samples will be analyzed using 4D deep urinary proteomics and machine learning to identify proteins linked to treatment response. Some participants' tumor tissues will also be used to create organoid models for further testing.
Detailed description
Neoadjuvant therapy is one of the main treatment strategies for patients with locally advanced colorectal cancer (LACC). However, the response to neoadjuvant therapy varies greatly among individuals, presenting a significant clinical challenge in accurately predicting therapeutic efficacy before treatment and dynamically assessing response during therapy. Commonly used clinical methods-such as imaging techniques, tissue biomarkers, and liquid biomarkers-often suffer from low sensitivity and specificity.
In our previous research, we applied 4D deep urinary proteomics to analyze pre-treatment urine samples from patients classified as responders and non-responders to neoadjuvant therapy. The results demonstrated that urinary proteomic profiles reflect differences in the tumor microenvironment associated with treatment response and hold promise for predicting therapeutic efficacy.
Building on this foundation, the current project aims to optimize the 4D deep urinary proteomics workflow and perform comparative analyses of urine samples collected before and after neoadjuvant therapy. Machine learning algorithms will be employed to identify candidate urinary proteins associated with treatment response, and key proteins will be validated using targeted proteomics and immunological techniques. Additionally, patient-derived organoid (PDO) models will be used to explore the biological functions of candidate proteins and elucidate their roles in mediating sensitivity to neoadjuvant therapy.
This study is expected to enable precise stratification of LACC patients and support the implementation of personalized treatment strategies. Furthermore, it may uncover mechanisms of resistance and propose novel therapeutic approaches to improve clinical decision-making and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nCRT group | – | –Diagnosed with rectal cancer and receiving neoadjuvant chemoradiotherapy. |
| chemotherapy group | – | –Diagnosed with colorectal cancer and receiving neoadjuvant chemoradiotherapy. |
| immunochemotherapy group | – | –Diagnosed with colorectal cancer and receiving neoadjuvant immunochemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll patients aged 18 to 75 years with a pathologically confirmed diagnosis of locally advanced colorectal cancer (LACC), defined as clinical stage cT3-4 and/or N+ without distant metastasis (M0) as determined by imaging (CT and/or PET-CT). Eligible participants must be treatment-naïve, with no prior exposure to anti-tumor therapies such as chemotherapy, targeted therapy, or immunotherapy. All patients must be clinically assessed as suitable candidates for neoadjuvant therapy followed by surgical resection and must be able to tolerate and complete the prescribed treatment regimen. In addition, participants must be willing and able to provide urine samples before and after neoadjuvant therapy and must sign written informed consent prior to enrollment. Patients will be excluded if they have a history of or concurrent diagnosis of other malignancies; suffer from serious hepatic, renal, cardiovascular, or metabolic conditions that may interfere with urinary protein metab
Key inclusion criteria (8 listed)
- Aged 18-75 years;
- Pathologically confirmed diagnosis of locally advanced colorectal cancer (cT3-4 and/or N+);
- Planned to undergo neoadjuvant therapy followed by surgical resection;
- No evidence of distant metastasis (M0) confirmed by imaging (CT and/or PET-CT);
- Clinically assessed as being able to tolerate and complete the full course of neoadjuvant treatment;
Key exclusion criteria (5 listed)
- History of or concurrent diagnosis with other malignancies;
- Presence of severe hepatic, renal, cardiovascular, or metabolic diseases that may affect urinary protein metabolism;
- Recent use of medications known to affect protein metabolism (e.g., glucocorticoids, high-dose antibiotics);
- Urinary tract infection or other diseases known to cause abnormal urinary protein levels (e.g., nephrotic syndrome);
- Any other condition deemed unsuitable for enrollment by the investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor regression grade
Time frame: through study completion, an average of 3 months
Tumor regression after neoadjuvant therapy (based on pathological analysis of the resected specimen)
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 28 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to concerns regarding patient privacy and confidentiality, as well as institutional regulations on data sharing.
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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.
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 (CRC) and Neoadjuvant Therapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 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 28 Nov 2025. 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?
Contact Qian Liu, M.D. (+8613601008906, fcwpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor regression grade (time frame: through study completion, an average of 3 months). 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 28 Nov 2025.