Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University
About this trial
Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over 18 years of age.
Voluntarily sign informed consent.
The pathological diagnosis was nasopharyngeal carcinoma, head and neck tumor.
Need to be treated with radiotherapy.
Disqualifiers
There are contraindications to radiotherapy.
Combined with other tumors.
Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), and mental illness.
At the investigator's discretion, those who was not considered to be suitable for participation in the study.
Trial population
Patients with nasopharyngeal carcinoma and head and neck tumors requiring 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
Different grades radiotherapy-induced oral mucositis
The incidence different grades of radiotherapy-induced oral mucositis will be calculated.
Time frame
Through study completion, up to 3 yearsSecondary outcomes
1
Start and duration of radiotherapy-induced oral mucositis
Calculated the onset time and duration of radiotherapy-induced oral mucositis.
Time frame
Through study completion, up to 3 years2
Side effects of radiotherapy
Record other early or late side effects caused by radiotherapy.
Time frame
Through study completion, up to 3 years3
Tumor response
The efficacy of tumor therapy was evaluated based on RECIST 1.1.
Time frame
Through study completion, up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov