Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma, Head and Neck Cancer, Radiotherapy-induced Oral Mucositis, Biomarker. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Cohort Study of Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
Overview
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.
Primary outcome measures
- Different grades radiotherapy-induced oral mucositis [Time frame: Through study completion, up to 3 years]
Secondary outcome measures (3)
- Start and duration of radiotherapy-induced oral mucositis [Time frame: Through study completion, up to 3 years]
- Side effects of radiotherapy [Time frame: Through study completion, up to 3 years]
- Tumor response [Time frame: Through study completion, up to 3 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 5 centers
- Nanfang hospital, Southern medical university — Guangzhou
- Fujian Provinical Hospital — Fuzhou
- Huizhou Central People's Hospital — Huizhou
- Jieyang People's Hospital — Jieyang
- Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou — Meizhou
Identifiers
NCT: NCT06307314 · NFEC-2024-093