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Not yet recruitingNCT07071688Updated Jul 17, 2025

Study of Peripheral Blood CHI3L1 to Predict Tumor Response to Radiotherapy

An observational study in Tumor, Radiotherapy and Biomarker, sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.

Sponsored by Nanfang Hospital, Southern Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
338
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Tumor
  • Radiotherapy
  • Biomarker

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Keywords

  • Tumor
  • Radiotherapy
  • Radioresistance
  • CHI3L1
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 338 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with tumors who require radiotherapy

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

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.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
338 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Objective Response Rate(ORR)

    Objective Response Rate (ORR) after Radiotherapy in Tumor Patients

    Time frame: Through study completion, up to 3 years

Secondary outcomes

  1. Local Control Rate

    Local Control Rate after Radiotherapy in Tumor Patients

    Time frame: Through study completion, up to 3 years

  2. Local Relapse Free Survival

    Locoregional Recurrence-Free Survival after Radiotherapy in Tumor Patients

    Time frame: Through study completion, up to 3 years

  3. Progression Free Survival

    Progression-Free Survival after Radiotherapy in Tumor Patients

    Time frame: Through study completion, up to 3 years

  4. Overall Survival

    Overall Survival after Radiotherapy in Tumor Patients

    Time frame: Through study completion, up to 3 years

07

Study locations

3 sites
  • Nanfang hospital, Southern medical university, Guangzhou, Guangdong 510515
    Guangzhou, Guangzhou Guangdong 510515, China
    • Jian Guan Ph.D. · Contact
  • Huizhou Central People's Hospital, Huizhou
    Huizhou, China
    • Yunming Tian · Contact
  • Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou, Meizhou,
    Meizhou, China
    • Jianda Sun · Contact
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07071688
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Jul 17, 2025
Start date
Jul 20, 2025 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jul 17, 2025

Study contacts

Jian Guan Ph.D.
Contact
guanjian5461@163.com
+8613632102247

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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