Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis

Recruiting now

Conditions studied: Nasopharyngeal Carcinoma, Head and Neck Cancer, Radiotherapy-induced Oral Mucositis, Biomarker

In brief

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.

Key facts

Study ID

NCT06307314

Run by

Nanfang Hospital, Southern Medical University

People needed

300

Starts

2024-02-01

Expected to finish

2026-12-31

Last updated by the study team

2024-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• ECOG PS Score: 0/1.

You may not qualify if…

• 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.

Where it is running

• Nanfang hospital, Southern medical university — Guangzhou, Guangdong, China (enrolling)
• Fujian Provinical Hospital — Fuzhou, China
• Huizhou Central People's Hospital — Huizhou, China
• Jieyang People's Hospital — Jieyang, China
• Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou — Meizhou, China

Full record on ClinicalTrials.gov

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