Clinical trial NCT06307314: Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
Official title: A Prospective Cohort Study of Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Carcinoma
Head and Neck Cancer
Radiotherapy-induced Oral Mucositis
Biomarker
Keywords: SAA1
Radiotherapy-induced Oral Mucositis
Head and Neck Cancer
Nasopharyngeal Carcinoma
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with nasopharyngeal carcinoma and head and neck tumors requiring radiotherapy.

Brief 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 criteria: 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 outcomes:
measure: Different grades radiotherapy-induced oral mucositis
timeFrame: Through study completion, up to 3 years
Secondary outcomes:
measure: Start and duration of radiotherapy-induced oral mucositis
timeFrame: Through study completion, up to 3 years
measure: Side effects of radiotherapy
timeFrame: Through study completion, up to 3 years
measure: Tumor response
timeFrame: Through study completion, up to 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang hospital, Southern medical university
state: Guangdong
city: Fuzhou
country: China
facility: Fujian Provinical Hospital
city: Huizhou
country: China
facility: Huizhou Central People's Hospital
city: Jieyang
country: China
facility: Jieyang People's Hospital
city: Meizhou
country: China
facility: Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jian Guan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: