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NCT Number: NCT07071688

Study of Peripheral Blood CHI3L1 to Predict Tumor Response to Radiotherapy

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.

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Key information

Conditions

Tumor Biomarker Neoplasms Radiotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang hospital, Southern medical university, Guangzhou, Guangdong 510515, Guangzhou, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Objective Response Rate（ORR）

    Time frame: Through study completion, up to 3 years

    Objective Response Rate (ORR) after Radiotherapy in Tumor Patients

Secondary outcomes

  1. Local Control Rate

    Time frame: Through study completion, up to 3 years

    Local Control Rate after Radiotherapy in Tumor Patients

  2. Local Relapse Free Survival

    Time frame: Through study completion, up to 3 years

    Locoregional Recurrence-Free Survival after Radiotherapy in Tumor Patients

  3. Progression Free Survival

    Time frame: Through study completion, up to 3 years

    Progression-Free Survival after Radiotherapy in Tumor Patients

  4. Overall Survival

    Time frame: Through study completion, up to 3 years

    Overall Survival after Radiotherapy in Tumor Patients

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Guan Ph.D.

CONTACT

[email protected]

+8613632102247

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

Predictive Value of Peripheral Blood CHI3L1 for Tumor Radiosensitivity: A Prospective and Retrospective Cohort Study

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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