Comparative Study of New Classification and Traditional Classification of Radioactive Oropharyngeal Mucositis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

The subjects in this study were head and neck tumor patients receiving radiotherapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, up to 3 years

Secondary outcomes

1

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.

Time frame
Through study completion, up to 3 years
2

The assessment period

The assessment times used respectively for different assessment methods

Time frame
Through study completion, up to 3 years
3

the satisfaction of patients

the satisfaction of patients

Time frame
Through study completion, up to 3 years
4

the satisfaction of doctors

the satisfaction of doctors

Time frame
Through study completion, up to 3 years

Other outcomes

1

Exploration of blood biomarkers related to the classification of radioactive oropharyngeal mucositis

Exploration of blood biomarkers related to the classification of radioactive oropharyngeal mucositis

Time frame
Through study completion, up to 3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.