Head and neck malignant tumors
Conditions
Interventions
Internal validation set:Radiotherapy
Training set:Radiotherapy
External validation set:Radiotherapy
Sponsors
THE FIRST HOSPITAL OF CHINA MEDICAL UNIVERSITY
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed malignant tumor of the head and neck. 2.Planned to receive radiotherapy or radiotherapy combined with systemic therapy (chemotherapy, targeted therapy, or immunotherapy). 3.ECOG performance status 0–1. 4.No contraindications to chemotherapy, targeted therapy, immunotherapy, or radiotherapy. 5.Women of childbearing potential must use reliable contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use effective contraception during the study; male participants with partners of childbearing potential must use effective contraception during the study.
Exclusion criteria
Exclusion criteria: 1.Previous or concurrent other malignancies that are not cured, except cured head and neck malignancies. 2.Active autoimmune diseases or a history of autoimmune diseases (e.g., interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [patients on stable hormone replacement therapy may be included]); patients with vitiligo or childhood asthma that has completely resolved without adult intervention may be included, whereas those requiring bronchodilator therapy are excluded. 3.Uncontrolled cardiovascular disease: myocardial ischemia or infarction = Grade II; poorly controlled arrhythmias (including QTc interval = 470 ms); NYHA Class III–IV heart failure; left ventricular ejection fraction (LVEF) < 50% on echocardiography; or myocardial infarction within the past year. 4.Deemed unsuitable for radiotherapy by the physician. 5.Participation in another clinical study within 4 weeks prior to the first radiotherapy session (or during follow-up, calculated from the last use of an investigational drug or device). 6.Pregnant or breastfeeding women. 7.Other conditions judged by the investigator to potentially lead to premature withdrawal, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, severely abnormal laboratory values, or family/social factors that may affect participant safety or data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of multi-omics model in predicting the onset timing of severe oral mucositis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of the multi-omics model for predicting severe oral mucositis;Incidence, onset, and duration of severe oral mucositis;Incidence, onset time, and duration of long-term adverse events (e.g., dysphagia); | — |
Countries
China
Contacts
Public ContactQiao Qiao
THE FIRST HOSPITAL OF CHINA MEDICAL UNIVERSITY
Outcome results
None listed