NCT06307327 Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis
| NCT ID | NCT06307327 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Head and Neck Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 264 participants |
| Start Date | 2025-09 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 264 participants in total. It began in 2025-09 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Jian Guan, M.D
PRINCIPAL INVESTIGATOR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT06307327 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06307327 currently recruiting?
Yes, NCT06307327 is actively recruiting participants. Contact the research team at guanjian5461@163.com for enrollment information.
Where is the NCT06307327 trial being conducted?
This trial is being conducted at Guangzhou, China, Huizhou, China, Jieyang, China, Meizhou, China.
Who is sponsoring the NCT06307327 clinical trial?
NCT06307327 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Jian Guan, M.D at Nanfang Hospital, Southern Medical University. The trial plans to enroll 264 participants.
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