Status:

RECRUITING

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

Lead Sponsor:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Conditions:

Colorectal Cancer (CRC)

Neoadjuvant Therapy

Eligibility:

All Genders

18-75 years

Brief 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. 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, ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

May 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2029

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT06904677

Start Date

May 1 2025

End Date

May 1 2029

Last Update

November 28 2025

Active Locations (1)

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Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Chaoyang District, China, 100021