NCT06904677Recruiting
Using 4D Urinary Proteomics to Predict and Evaluate Treatment Response in Colorectal Cancer
Predicting and Evaluating the Efficacy of Neoadjuvant Therapy in Colorectal Cancer Based on 4D Deep Urinary Proteomics Technology
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 24 Mar 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 May 2027
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Colorectal cancer
- NCT number
- NCT06904677
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 May 2025 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of or concurrent diagnosis with other malignancies;
- Recent use of medications known to affect protein metabolism (e.g., glucocorticoids, high-dose antibiotics);
Other illness
- Presence of severe hepatic, renal, cardiovascular, or metabolic diseases that may affect urinary protein metabolism;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.