TumorNCT07071688
Study of Peripheral Blood CHI3L1 to Predict Tumor Response to Radiotherapy
An observational study of Tumor and Radiotherapy, run by Nanfang Hospital, Southern Medical University at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Radiotherapy, Biomarker
- How many people
- 338 participants
- Where
- 3 sitesChina
- Study dates
- 20 Jul 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tumors who require radiotherapy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Nanfang hospital, Southern medical university, Guangzhou, Guangdong 510515
Guangzhou, Guangzhou, Guangdong 510515
Jian Guan Ph.D.
Huizhou Central People's Hospital, Huizhou
Huizhou
Yunming Tian
Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou, Meizhou,
Meizhou
Jianda Sun
About this study
Official title: Predictive Value of Peripheral Blood CHI3L1 for Tumor Radiosensitivity: A Prospective and Retrospective Cohort Study
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
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
Objective Response Rate (ORR) after Radiotherapy in Tumor Patients
Measured: Through study completion, up to 3 years
Secondary outcomes (4)
Local Control Rate
Local Control Rate after Radiotherapy in Tumor Patients
Measured: Through study completion, up to 3 years
Local Relapse Free Survival
Locoregional Recurrence-Free Survival after Radiotherapy in Tumor Patients
Measured: Through study completion, up to 3 years
Progression Free Survival
Progression-Free Survival after Radiotherapy in Tumor Patients
Measured: Through study completion, up to 3 years
Overall Survival
Overall Survival after Radiotherapy in Tumor Patients
Measured: Through study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start20 Jul 2025 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071688
- Sponsor's protocol ID
- NFEC-2025-292
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Peripheral Blood CHI3L1 for Tumor Radiosensitivity: A Prospective and Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07071688
- Acronym / sponsor ID
- NFEC-2025-292
- Conditions
- Tumor, Radiotherapy, Biomarker
- Keywords
- Tumor, Radiotherapy, Radioresistance, CHI3L1
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tumors who require radiotherapy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective Response Rate（ORR）
Time frame: Through study completion, up to 3 years
Objective Response Rate (ORR) after Radiotherapy in Tumor Patients
4 secondary outcomes
Local Control Rate
Time frame: Through study completion, up to 3 years
Local Relapse Free Survival
Time frame: Through study completion, up to 3 years
Progression Free Survival
Time frame: Through study completion, up to 3 years
Overall Survival
Time frame: Through study completion, up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor and Radiotherapy, run by Nanfang Hospital, Southern Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Guan Ph.D. (+8613632102247, guanjian5461@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate（ORR） (time frame: Through study completion, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.