Assessing SAA1 Levels to Predict Oral Mucositis from Radiotherapy
Official title: A Prospective Cohort Study of Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
Run by Nanfang Hospital, Southern Medical University · NCT06307314 · Data updated 2026-11-12
This study is testing if measuring a specific protein in the blood can help predict how severe mouth sores will be for patients with head and neck cancer who are getting radiation treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 12, 2024 |
| Trial ID | NCT06307314 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years old with a confirmed diagnosis of nasopharyngeal carcinoma or head and neck tumors who are scheduled to receive radiotherapy.
✕Probably not a fit
Patients with contraindications to radiotherapy or those with serious coexisting medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the levels of serum amyloid A1 (SAA1) as a biomarker for predicting the response to radiotherapy-induced oral mucositis in patients with nasopharyngeal carcinoma and head and neck tumors. By measuring SAA1 levels before and after radiotherapy, the study seeks to understand the relationship between inflammation and the severity of oral mucositis. The study will be conducted across multiple centers, focusing on patients who are undergoing radiotherapy for their cancer treatment. The findings could help in tailoring treatment plans to minimize side effects and improve patient quality of life.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for preventing and treating oral mucositis in patients undergoing radiotherapy.
How similar studies have gone: While the use of SAA1 as a biomarker in this context is novel, previous studies have indicated the potential of biomarkers in predicting treatment responses in cancer patients.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Nanfang hospital, Southern medical university
Guangzhou, Guangdong, China 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
Study contacts
- Principal investigator: Jian Guan, Ph.D. — Nanfang Hospital, Southern Medical University
- Study coordinator: Jian Guan, Ph.D.
- Email: guanjian5461@163.com
- Phone: +8613632102247
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.