RecruitingNCT06307314

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

A Prospective Cohort Study of Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

300 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether measuring a blood protein called SAA1 (serum amyloid A1) can predict how much mouth and throat soreness (oral mucositis) a patient will develop during radiation therapy for head and neck cancer, potentially allowing doctors to personalize treatment. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with nasopharyngeal carcinoma or another head and neck tumor by biopsy - You are scheduled to receive radiation therapy - Your general health score (ECOG) is 0 or 1 **You may NOT be eligible if...** - You have a medical reason that prevents you from receiving radiation - You have another active tumor at the same time - You have uncontrolled serious medical conditions such as unstable heart disease, chronic hepatitis, kidney disease, poorly controlled diabetes, or a serious mental illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(5)

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, China

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

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NCT06307314


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