Using 4D Urinary Proteomics to Predict and Evaluate Treatment Response in Colorectal Cancer

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Mar 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how certain proteins found in urine can help predict how patients with locally advanced colorectal cancer (LACC) will respond to a specific treatment called neoadjuvant therapy. Neoadjuvant therapy is given before surgery to help shrink the tumor. Researchers want to find out if analyzing these urinary proteins can give valuable insights into whether the treatment is working for the patient. Participants will provide urine samples before they start treatment and after it ends, which will be examined to identify any protein markers linked to treatment response. Some patients' tumor tissues may also be used for further testing.

To be eligible for this trial, participants need to be between 18 and 75 years old, have a confirmed diagnosis of locally advanced colorectal cancer, and be planning to undergo neoadjuvant therapy followed by surgery. They should not have any distant spread of cancer and must be healthy enough to complete the treatment. Participants will need to agree to provide urine samples and sign an informed consent form. This trial is not yet recruiting participants, but it aims to gather important information that could help improve treatment predictions for patients with colorectal cancer in the future.

Gender

ALL

Eligibility criteria

• 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.