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.
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);
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);
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
Cohort
Prospective
Not listed
Tumor regression grade
Tumor regression after neoadjuvant therapy (based on pathological analysis of the resected specimen)
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