Nasopharyngeal CarcinomaNCT06307314
Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
An observational study of Nasopharyngeal Carcinoma and Head and Neck Cancer, run by Nanfang Hospital, Southern Medical University at 5 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma, Head and Neck Cancer, Radiotherapy-induced Oral Mucositis
- How many people
- 300 participants
- Where
- 5 sitesChina
- Study dates
- 1 Feb 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with nasopharyngeal carcinoma and head and neck tumors requiring radiotherapy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Fujian Provinical Hospital
Fuzhou
Yongmei Dai
- Recruiting
Nanfang hospital, Southern medical university
Guangzhou, Guangdong, 510515
Jian Guan, Ph.D.
- Not yet recruiting
Huizhou Central People's Hospital
Huizhou
Yunming Tian
- Not yet recruiting
Jieyang People's Hospital
Jieyang
Peibao Lai
- Not yet recruiting
Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou
Meizhou
Jianda Sun
About this study
Official title: 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.
- Conditions
- Nasopharyngeal Carcinoma, Head and Neck Cancer, Radiotherapy-induced Oral Mucositis, Biomarker
- Keywords
- SAA1, Radiotherapy-induced Oral Mucositis, Head and Neck Cancer, Nasopharyngeal Carcinoma
- Medical subject headings
- Nasopharyngeal Carcinoma, Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Different grades radiotherapy-induced oral mucositis
The incidence different grades of radiotherapy-induced oral mucositis will be calculated.
Measured: Through study completion, up to 3 years
Secondary outcomes (3)
Start and duration of radiotherapy-induced oral mucositis
Calculated the onset time and duration of radiotherapy-induced oral mucositis.
Measured: Through study completion, up to 3 years
Side effects of radiotherapy
Record other early or late side effects caused by radiotherapy.
Measured: Through study completion, up to 3 years
Tumor response
The efficacy of tumor therapy was evaluated based on RECIST 1.1.
Measured: Through study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Feb 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Guan, Ph.D., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307314
- Sponsor's protocol ID
- NFEC-2024-093
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis
- ClinicalTrials.gov ID
- NCT06307314
- Acronym / sponsor ID
- NFEC-2024-093
- Conditions
- Nasopharyngeal Carcinoma, Head and Neck Cancer, Radiotherapy-induced Oral Mucositis, Biomarker
- Keywords
- SAA1, Radiotherapy-induced Oral Mucositis, Head and Neck Cancer, Nasopharyngeal Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with nasopharyngeal carcinoma and head and neck tumors requiring radiotherapy.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Guan, Ph.D. principal investigator
Nanfang Hospital, Southern Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma and Head and Neck Cancer, run by Nanfang Hospital, Southern Medical University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Guan, Ph.D. (+8613632102247, guanjian5461@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Different grades radiotherapy-induced oral mucositis (time frame: Through study completion, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.