Study of Peripheral Blood CHI3L1 to Predict Tumor Response to Radiotherapy

NCT07071688 | Not Yet Recruiting

• 1 other identifier: NFEC-2025-292
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 3

Brief Summary

Radiotherapy is an important treatment for many malignant tumors. However, radioresistance remains a major cause of treatment failure, often leading to tumor recurrence or progression. As a key factor affecting prognosis, radioresistance currently lacks reliable methods for identifying high-risk individuals before treatment. Liquid biopsy, as a non-invasive and dynamic monitoring tool, offers unique advantages for real-time assessment. Previous studies from our group have shown that peripheral blood levels of CHI3L1 are significantly elevated in patients with radioresistant tumors and may serve as a predictive biomarker for radiotherapy sensitivity. This study aims to conduct a multicenter, bidirectional cohort study to systematically evaluate the predictive value of peripheral blood CHI3L1 as a pan-cancer biomarker for tumor response to radiotherapy.

Conditions

Tumor; Radiotherapy; Biomarker

Keywords

Tumor; Radiotherapy; Radioresistance; CHI3L1

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate（ORR）

  Objective Response Rate (ORR) after Radiotherapy in Tumor Patients

  Through study completion, up to 3 years

Secondary Outcomes (4)

• Local Control Rate

  Through study completion, up to 3 years

• Local Relapse Free Survival

  Through study completion, up to 3 years

• Progression Free Survival

  Through study completion, up to 3 years

• Overall Survival

  Through study completion, up to 3 years

Eligibility Criteria

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

Study Population

Patients with tumors who require radiotherapy

You may qualify if:

• Voluntarily signed informed consent form;
• Age ≥ 18 years;
• No restrictions on sex;
• Histologically confirmed diagnosis of one of the following malignant tumors: nasopharyngeal carcinoma, head and neck cancer, lung cancer, breast cancer, gastric cancer, colorectal cancer, glioma, esophageal cancer, liver cancer, cholangiocarcinoma, cervical cancer, prostate cancer, or bladder cancer;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

You may not qualify if:

• Patients with any serious comorbidities that may pose an unacceptable risk or adversely affect compliance with the study protocol. Examples include unstable heart disease requiring treatment, chronic hepatitis, renal disease with poor clinical status, uncontrolled diabetes mellitus (fasting blood glucose \> 1.5 × ULN), or psychiatric disorders.
• Deemed unsuitable for participation in the study at the discretion of the investigators.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (3)

Nanfang hospital, Southern medical university, Guangzhou, Guangdong 510515

Guangzhou, Guangzhou, Guangdong 510515, China

Location

Huizhou Central People's Hospital, Huizhou

Huizhou, China

Location

Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou, Meizhou,

Meizhou, China

Location

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Jian Guan Ph.D.

CONTACT

+8613632102247; guanjian5461@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)