Actively Recruiting
A Prospective Cohort Study of Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
Led by Nanfang Hospital, Southern Medical University · Updated on 2024-03-12
300
Participants Needed
5
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Head and neck squamous cell carcinoma (SCC) is a common cancer worldwide, causing many new cases and deaths each year. Radiotherapy is important to control the recurrence of these tumors, but it often causes acute inflammation such as radiotherapy-induced oral mucositis (RIOM), which can affect patients' quality of life and treatment effectiveness. Researchers are studying plasma levels of Serum amyloid A1 (SAA1), a protein linked to inflammation, to see if it can help predict the onset and severity of RIOM early in patients receiving radiotherapy for nasopharyngeal carcinoma or other head and neck tumors. This is a prospective, multicenter, observational study where participants with nasopharyngeal carcinoma or head and neck tumors who need radiotherapy will be followed. Plasma SAA1 levels will be measured to explore their ability to predict radiotherapy-induced oral mucositis. The study will track the development, start time, duration, and severity of oral mucositis along with other side effects of radiotherapy and tumor response over a period of up to three years. Participants will be monitored throughout radiotherapy and afterward for up to three years to assess different grades of oral mucositis and other side effects. The study will collect clinical data, observe tumor response, and evaluate plasma SAA1 levels as a biomarker. This long-term observation aims to improve early screening and prevention strategies for radiotherapy-induced oral mucositis, enhancing patient care during and after radiotherapy.
CONDITIONS
Brief Title
Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age
- Voluntarily sign informed consent
- Pathological diagnosis of nasopharyngeal carcinoma or head and neck tumor
- Need to be treated with radiotherapy
- ECOG Performance Status Score of 0 or 1
You will not qualify if you...
- Contraindications to radiotherapy
- Having other tumors in addition to the primary diagnosis
- Serious coexisting medical conditions such as unstable heart disease, chronic hepatitis, kidney disease, uncontrolled diabetes, or mental illness
- Considered unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants are monitored to observe the development and duration of radiotherapy-induced oral mucositis and other side effects, as well as tumor response.
Visits scheduled throughout the study period depending on treatment and monitoring needs
Trial Site Locations
Total: 5 locations
1
Nanfang hospital, Southern medical university
Guangzhou, Guangdong, China, 510515
Actively Recruiting
2
Fujian Provinical Hospital
Fuzhou, China
Not Yet Recruiting
3
Huizhou Central People's Hospital
Huizhou, China
Not Yet Recruiting
4
Jieyang People's Hospital
Jieyang, China
Not Yet Recruiting
5
Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
Meizhou, China
Not Yet Recruiting
Research Team
J
Jian Guan, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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