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

NCT06904677 | Recruiting

• 1 other identifier: NCC2025C-464
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Colorectal Cancer (CRC); Neoadjuvant Therapy; Proteomics

Keywords

Colorectal caner; Neoadjuvant therapy; Urinary proteomics

Outcome Measures

Primary Outcomes (1)

• Tumor regression grade

  Tumor regression after neoadjuvant therapy (based on pathological analysis of the resected specimen)

  through study completion, an average of 3 months

Study Arms (3)

nCRT group

Diagnosed with rectal cancer and receiving neoadjuvant chemoradiotherapy.

chemotherapy group

Diagnosed with colorectal cancer and receiving neoadjuvant chemoradiotherapy.

immunochemotherapy group

Diagnosed with colorectal cancer and receiving neoadjuvant immunochemotherapy.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Chaoyang District, 100021, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Qian Liu, M.D.

CONTACT

+8613601008906; fcwpumch@163.com

Mingguang Zhang, M.D.

CONTACT

+8613261967603; zmgslimshady@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 1, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2029
• Last Updated: November 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)