Urine protein markers to predict and monitor response to pre-surgery therapy in colorectal cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational project in which patients with locally advanced colorectal cancer provide urine samples before and after neoadjuvant therapy. Samples will be analyzed using optimized 4D deep urinary proteomics and machine learning to identify proteins associated with treatment response. Key candidate proteins will be validated using targeted proteomics and immunological methods. Selected tumor tissues will be used to create patient-derived organoids to explore the biological roles of the identified proteins in therapy sensitivity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18-75 years;
2. Pathologically confirmed diagnosis of locally advanced colorectal cancer (cT3-4 and/or N+);
3. Planned to undergo neoadjuvant therapy followed by surgical resection;
4. No evidence of distant metastasis (M0) confirmed by imaging (CT and/or PET-CT);
5. Clinically assessed as being able to tolerate and complete the full course of neoadjuvant treatment;
6. No prior anti-tumor therapy (e.g., targeted therapy, immunotherapy) before the initiation of treatment;
7. Willing and able to provide urine samples as required;
8. Written informed consent obtained.

Exclusion Criteria:

1. History of or concurrent diagnosis with other malignancies;
2. Presence of severe hepatic, renal, cardiovascular, or metabolic diseases that may affect urinary protein metabolism;
3. Recent use of medications known to affect protein metabolism (e.g., glucocorticoids, high-dose antibiotics);
4. Urinary tract infection or other diseases known to cause abnormal urinary protein levels (e.g., nephrotic syndrome);
5. Any other condition deemed unsuitable for enrollment by the investigators.

Where it's running

• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Chaoyang District, China Recruiting

Study contacts

• Study coordinator: Qian Liu, M.D.
• Email: fcwpumch@163.com
• Phone: +8613601008906

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.