Head and Neck CancerNCT06307327
Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis
An observational study of Head and Neck Cancer and Radiation-Induced Mucositis, run by Nanfang Hospital, Southern Medical University at 4 sites in China.
Trial summary
Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Radiation-Induced Mucositis
- How many people
- 264 participants
- Where
- 4 sitesChina
- Study dates
- Sep 2025to Dec 2026
- 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: The subjects in this study were head and neck tumor patients receiving radiotherapy
Who may be able to join
- Voluntarily sign informed consent;
- Age 18 or older on the date of signing the informed consent;
- Histologically confirmed head and neck tumor, radiotherapy or chemoradiotherapy.
Who cannot join
- They also have other uncontrolled serious medical conditions, such as unstable heart disease requiring treatment, poorly controlled diabetes (fasting blood glucose > 1.5× the upper limit of normal), mental illness, and a history of severe allergies
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Southern medical university
Guangzhou, Guangdong, 510515
Jian Guan, M.D, 86+13632102247, guanjian5461@163.com
- Not yet recruiting
Huizhou Central People's Hospital
Huizhou, Guangdong, 516000
Yunming Tian
- Not yet recruiting
Jieyang people's hospital
Jieyang, Guangdong, 522000
Peibao Lai, 86+15975196057, boa71@139.com
- Not yet recruiting
Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
Meizhou, Guangdong, 514000
Jianda Sun
About this study
Official title: A Comparative Study on the Evaluation Consistency Between the New Type and the Traditional Grade of Radioactive Oropharyngeal Mucositis and the Exploration of Blood Markers
Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. To solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) Scattered erosion type; (3) Fusion erosion type; (4) Ulcer type. We intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples.
Read the detailed description
Since this is an observational study, no additional visits, laboratory analyses, or evaluations beyond the routine clinical practice requirements are necessary. Patients must sign the latest informed consent form (ICF) approved by the ethics committee before data collection is carried out. After obtaining the patient's consent, clinical routine diagnosis and treatment information will be collected.
The study is divided into three parts. The first part compares the consistency of results among different methods used to assess mucositis. The research process involves having different doctors assess the same patient at the same stage using a specific grading method three times, and taking the results of more than two of these assessments as the internal unified results of that grading method (each patient can be assessed and data recorded every 1-2 weeks during radiotherapy). After obtaining the internal unified results of the three mucositis grading methods, the consistency of results among different methods used for assessment is compared.
The second part first determines the internal consistency of doctor evaluations for four methods (the traditional three mucositis grading methods and the new classification method), and then uses the consistency results of each method to compare the stability of the assessments. The research process involves having different doctors assess the same patient at the same stage using a specific method three times. Each patient can be assessed and data recorded every 1-2 weeks during radiotherapy. The consistency of evaluations among different doctors for this method is obtained. Finally, this consistency is used to compare the stability of the assessments between different methods.
The third part compares the consistency of results between the assessment using the new mucositis classification method and the patient's self-assessment. The research process involves having different doctors assess the same patient at the same stage using the new classification method three times, and taking the results of more than two of these assessments as the internal unified result of the new classification method (each patient can be assessed and data recorded every 1-2 weeks during radiotherapy). After obtaining the internal unified results of the new classification method and the patient's self-assessment results, the consistency of results between using the new classification method and the patient's self-assessment is compared.
- Conditions
- Head and Neck Cancer, Radiation-Induced Mucositis
- Keywords
- Radiation oropharyngeal mucositis, Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater consistency among doctors
Different physician assessments of agreement (percentage) were directly compared between the new and traditional classifications. Consistency refers to the proportion of assessments made by two doctors that are the same.
Measured: Through study completion, up to 3 years
Secondary outcomes (4)
Consistency in assessment between doctors and patients
In the new classification, the consistency (percentage) of assessment between doctors and patients was compared. Consistency refers to the proportion of times where the assessments made by the two doctors were the same.
Measured: Through study completion, up to 3 years
The assessment period
The assessment times used respectively for different assessment methods
Measured: Through study completion, up to 3 years
the satisfaction of patients
the satisfaction of patients
Measured: Through study completion, up to 3 years
the satisfaction of doctors
the satisfaction of doctors
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 posted12 Mar 2024
- Study startSep 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Prospective
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Guan, M.D, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307327
- Sponsor's protocol ID
- NFEC-2024-098
- Status last verified
- Jul 2025
- First submitted
- 6 Mar 2024
- Last updated
- 16 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 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Evaluation Consistency Between the New Type and the Traditional Grade of Radioactive Oropharyngeal Mucositis and the Exploration of Blood Markers
- ClinicalTrials.gov ID
- NCT06307327
- Acronym / sponsor ID
- NFEC-2024-098
- Conditions
- Head and Neck Cancer, Radiation-Induced Mucositis
- Keywords
- Radiation oropharyngeal mucositis, Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Mar 2024 (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.
Radiation oropharyngeal mucositis is one of the most painful side effects of radiotherapy in patients with head and neck tumors. However, the traditional radioactive oropharyngeal mucositis grading system has the problem of poor evaluation consistency. To solve this problem, we innovatively classify radiation oropharyngeal mucositis into four types according to the four-stage histopathological changes of acute radiation injury: (1) congestive; (2) Scattered erosion type; (3) Fusion erosion type; (4) Ulcer type. We intend to conduct a multicenter observational cohort study to compare the consistency of different physicians in the assessment of radiation oropharyngeal mucositis with new and traditional classifications, and to explore changes in blood markers of different types of oropharyngeal mucositis using clinical residual blood samples.
Detailed description
Since this is an observational study, no additional visits, laboratory analyses, or evaluations beyond the routine clinical practice requirements are necessary. Patients must sign the latest informed consent form (ICF) approved by the ethics committee before data collection is carried out. After obtaining the patient's consent, clinical routine diagnosis and treatment information will be collected.
The study is divided into three parts. The first part compares the consistency of results among different methods used to assess mucositis. The research process involves having different doctors assess the same patient at the same stage using a specific grading method three times, and taking the results of more than two of these assessments as the internal unified results of that grading method (each patient can be assessed and data recorded every 1-2 weeks during radiotherapy). After obtaining the internal unified results of the three mucositis grading methods, the consistency of results among different methods used for assessment is compared.
The second part first determines the internal consistency of doctor evaluations for four methods (the traditional three mucositis grading methods and the new classification method), and then uses the consistency results of each method to compare the stability of the assessments. The research process involves having different doctors assess the same patient at the same stage using a specific method three times. Each patient can be assessed and data recorded every 1-2 weeks during radiotherapy. The consistency of evaluations among different doctors for this method is obtained. Finally, this consistency is used to compare the stability of the assessments between different methods.
The third part compares the consistency of results between the assessment using the new mucositis classification method and the patient's self-assessment. The research process involves having different doctors assess the same patient at the same stage using the new classification method three times, and taking the results of more than two of these assessments as the internal unified result of the new classification method (each patient can be assessed and data recorded every 1-2 weeks during radiotherapy). After obtaining the internal unified results of the new classification method and the patient's self-assessment results, the consistency of results between using the new classification method and the patient's self-assessment is compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects in this study were head and neck tumor patients receiving radiotherapy
Key inclusion criteria (3 listed)
- Voluntarily sign informed consent;
- Age 18 or older on the date of signing the informed consent;
- Histologically confirmed head and neck tumor, radiotherapy or chemoradiotherapy.
Key exclusion criteria (1 listed)
- They also have other uncontrolled serious medical conditions, such as unstable heart disease requiring treatment, poorly controlled diabetes (fasting blood glucose > 1.5× the upper limit of normal), mental illness, and a history of severe allergies
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
Inter-rater consistency among doctors
Time frame: Through study completion, up to 3 years
Different physician assessments of agreement (percentage) were directly compared between the new and traditional classifications. Consistency refers to the proportion of assessments made by two doctors that are the same.
4 secondary outcomes
Consistency in assessment between doctors and patients
Time frame: Through study completion, up to 3 years
The assessment period
Time frame: Through study completion, up to 3 years
the satisfaction of patients
Time frame: Through study completion, up to 3 years
the satisfaction of doctors
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 16 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.
Jian Guan, M.D principal investigator
Nanfang Hospital, Southern Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Radiation-Induced Mucositis, run by Nanfang Hospital, Southern Medical University at 4 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 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 4 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, M.D (+86-13632102247, guanjian5461@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater consistency among doctors (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 16 Jul 2025.