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

NCT06307314 · tracked via the Priya Life Science China tracker

Sponsor

Nanfang Hospital, Southern Medical University

Phase

Observational

Started

2024-02-01

Last updated

2024-03-12

Condition(s) studied

Nasopharyngeal CarcinomaHead and Neck CancerRadiotherapy-induced Oral MucositisBiomarker

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Different grades radiotherapy-induced oral mucositis — Through study completion, up to 3 years
The incidence different grades of radiotherapy-induced oral mucositis will be calculated.

Trial sites (5)

Facility	City	Region	Status
Nanfang hospital, Southern medical university	Guangzhou	Guangdong	Recruiting
Fujian Provinical Hospital	Fuzhou	China	Not Yet Recruiting
Huizhou Central People's Hospital	Huizhou	China	Not Yet Recruiting
Jieyang People's Hospital	Jieyang	China	Not Yet Recruiting
Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou	Meizhou	China	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06307314 on ClinicalTrials.gov ↗ ← All trials in China