NCT06307314Recruiting
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 6 Mar 2024
- Start date
- 1 Feb 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Head and neck cancer
- NCT number
- NCT06307314
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Feb 2024 to the primary completion date, 1 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- There are contraindications to radiotherapy.
Lab values
- 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.
Other
- Combined with other tumors.
- At the investigator's discretion, those who was not considered to be suitable for participation in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Provinical Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Not yet recruiting |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Huizhou Central People's Hospital Coordinator of this site? Confirm its status | Huizhou | China | Not yet recruiting |
| Jieyang People's Hospital Coordinator of this site? Confirm its status | Jieyang | China | Not yet recruiting |
| Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou Coordinator of this site? Confirm its status | Meizhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.