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

March 6, 2024 updated by: Nanfang Hospital, Southern Medical University

A Prospective Cohort Study of Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Fuzhou, China
        • Not yet recruiting
        • Fujian Provinical Hospital
        • Contact:
          • Yongmei Dai
      • Huizhou, China
        • Not yet recruiting
        • Huizhou Central People's Hospital
        • Contact:
          • Yunming Tian
      • Jieyang, China
        • Not yet recruiting
        • Jieyang People's Hospital
        • Contact:
          • Peibao Lai
      • Meizhou, China
        • Not yet recruiting
        • Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
        • Contact:
          • Jianda Sun
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
          • Jian Guan, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Different grades radiotherapy-induced oral mucositis
Time Frame: Through study completion, up to 3 years
The incidence different grades of radiotherapy-induced oral mucositis will be calculated.
Through study completion, up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Start and duration of radiotherapy-induced oral mucositis
Time Frame: Through study completion, up to 3 years
Calculated the onset time and duration of radiotherapy-induced oral mucositis.
Through study completion, up to 3 years
Side effects of radiotherapy
Time Frame: Through study completion, up to 3 years
Record other early or late side effects caused by radiotherapy.
Through study completion, up to 3 years
Tumor response
Time Frame: Through study completion, up to 3 years
The efficacy of tumor therapy was evaluated based on RECIST 1.1.
Through study completion, up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Investigators

  • Principal Investigator: Jian Guan, Ph.D., Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2024-093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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