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

NCT06307314 | Recruiting

• 1 other identifier: NFEC-2024-093
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Nasopharyngeal Carcinoma; Head and Neck Cancer; Radiotherapy-induced Oral Mucositis; Biomarker

Keywords

SAA1; Radiotherapy-induced Oral Mucositis; Head and Neck Cancer; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Different grades radiotherapy-induced oral mucositis

  The incidence different grades of radiotherapy-induced oral mucositis will be calculated.

  Through study completion, up to 3 years

Secondary Outcomes (3)

• Start and duration of radiotherapy-induced oral mucositis

  Through study completion, up to 3 years

• Side effects of radiotherapy

  Through study completion, up to 3 years

• Tumor response

  Through study completion, up to 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with nasopharyngeal carcinoma and head and neck tumors requiring radiotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (5)

Nanfang hospital, Southern medical university

Guangzhou, Guangdong, 510515, 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

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and plasma

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jian Guan, Ph.D.

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Guan, Ph.D.

CONTACT

+8613632102247; guanjian5461@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 12, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)