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Study of Peripheral Blood CHI3L1 to Predict Tumor Response to Radiotherapy

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07071688
Enrollment
338
Registered
2025-07-17
Start date
2025-07-20
Completion date
2028-12-31
Last updated
2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarker, Radiotherapy, Tumor

Keywords

Tumor, Radiotherapy, Radioresistance, CHI3L1

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.

Interventions

None listed

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Objective Response Rate(ORR)Through study completion, up to 3 yearsObjective Response Rate (ORR) after Radiotherapy in Tumor Patients

Secondary

MeasureTime frameDescription
Local Control RateThrough study completion, up to 3 yearsLocal Control Rate after Radiotherapy in Tumor Patients
Local Relapse Free SurvivalThrough study completion, up to 3 yearsLocoregional Recurrence-Free Survival after Radiotherapy in Tumor Patients
Progression Free SurvivalThrough study completion, up to 3 yearsProgression-Free Survival after Radiotherapy in Tumor Patients
Overall SurvivalThrough study completion, up to 3 yearsOverall Survival after Radiotherapy in Tumor Patients

Countries

China

Contacts

Primary ContactJian Guan Ph.D.
guanjian5461@163.com+8613632102247

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026