NCT06307314 Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
| NCT ID | NCT06307314 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-02-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Jian Guan, Ph.D.
PRINCIPAL INVESTIGATOR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT06307314 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06307314 currently recruiting?
Yes, NCT06307314 is actively recruiting participants. Contact the research team at guanjian5461@163.com for enrollment information.
Where is the NCT06307314 trial being conducted?
This trial is being conducted at Guangzhou, China, Fuzhou, China, Huizhou, China, Jieyang, China and 1 additional location.
Who is sponsoring the NCT06307314 clinical trial?
NCT06307314 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Jian Guan, Ph.D. at Nanfang Hospital, Southern Medical University. The trial plans to enroll 300 participants.