Nasopharyngeal CarcinomaNCT06463392
Deep Learning-based sbORN Diagnostic Model
An observational study of Nasopharyngeal Carcinoma and Herpesvirus 4, Human, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Skull-base osteonecrosis (sbORN) is a severe long-term complication of nasopharyngeal carcinoma (NPC) post radiotherapy, which significantly diminish the quality of life, increase the risk of internal carotid artery rupture, and is frequently misdiagnosed as NPC recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma, Herpesvirus 4, Human
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Dec 2030
- 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: All populations that meet the eligibility criteria.
Who may be able to join
- Equal to or older than 18 years old.
- A history of histologically confirmed nonkeratinizing undifferentiated nasopharyngeal carcinoma.
- A history of radical radiotherapy at nasopharynx.
- Complete remission six months post radical radiotherapy according to RECIST 1.1.
- No evidence of distant metastasis upon recruitment.
- Diagnosis of sbORN given by senior radiologist with 2-4 Likert scores.
Show all 9Show fewer
- Consent to biopsy awake or under general anesthesia.
- Consent to perform blood tests, EBV DNA, EBV IgAs, and MRI inspection of nasopharynx and neck.
- With a written consent.
Who cannot join
- MRI artifacts or other factors that interfere radiological diagnosis and region of interest contouring.
- Suspected lesion is not confined to nasopharynx and skull-base.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Xiang-Wei Kong, Ph.D., 0086-020-34071439, kongxw8@mail.sysu.edu.cn
About this study
Official title: Development of Deep-Learning-Based Multimodal Post Radiotherapy Skull-Base Osteonecrosis and Recurrence of Nasopharyngeal Carcinoma Differential Diagnostic Model
Skull-base osteonecrosis (sbORN) is a severe long-term complication of nasopharyngeal carcinoma (NPC) post radiotherapy, which significantly diminish the quality of life, increase the risk of internal carotid artery rupture, and is frequently misdiagnosed as NPC recurrence. Novel diagnostic tools are therefore clinically significant. In this study, the investigators seek to ask if a deep-learning-based model shows a significantly higher sensitivity than radiologists. With a cross-sectional design, the investigators aim to recruit 312 participants in Sun Yat-sen Memorial Hospital, Guangzhou, China that meet the eligibility criteria.
- Conditions
- Nasopharyngeal Carcinoma, Herpesvirus 4, Human
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Nasopharyngeal Carcinoma, Skull-base Osteonecrosis, Radiotherapy, Epstein-Barr Virus
- Medical subject headings
- Nasopharyngeal Carcinoma, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention is scheduled for this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Case | Histologically confirmed sbORN that meets the eligibility criteria. Receives: Other: No Intervention: Observational Cohort | |
| Control | Histologically confirmed NPC recurrence that meets the eligibility criteria. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Measured: Baseline
Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Measured: Baseline
Secondary outcomes (12)
Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Measured: Baseline
Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Measured: Baseline
F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Measured: Baseline
Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Measured: Baseline
Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Measured: Baseline
Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Measured: Baseline
Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Measured: Baseline
F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Measured: Baseline
Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Measured: Baseline
Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Measured: Baseline
Dice similarity coefficient of the MRI contouring between the deep-learning-based multimodal model and the radiologists.
Measured: Baseline
Average surface distance of the MRI contouring between the deep-learning-based multimodal model and the radiologists.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (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.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463392
- Sponsor's protocol ID
- SYSKY-2024-395-03
- Status last verified
- Sep 2024
- First submitted
- 22 May 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Deep-Learning-Based Multimodal Post Radiotherapy Skull-Base Osteonecrosis and Recurrence of Nasopharyngeal Carcinoma Differential Diagnostic Model
- ClinicalTrials.gov ID
- NCT06463392
- Acronym / sponsor ID
- SYSKY-2024-395-03
- Conditions
- Nasopharyngeal Carcinoma, Herpesvirus 4, Human
- Keywords
- Nasopharyngeal Carcinoma, Skull-base Osteonecrosis, Radiotherapy, Epstein-Barr Virus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Jun 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.
Skull-base osteonecrosis (sbORN) is a severe long-term complication of nasopharyngeal carcinoma (NPC) post radiotherapy, which significantly diminish the quality of life, increase the risk of internal carotid artery rupture, and is frequently misdiagnosed as NPC recurrence. Novel diagnostic tools are therefore clinically significant. In this study, the investigators seek to ask if a deep-learning-based model shows a significantly higher sensitivity than radiologists. With a cross-sectional design, the investigators aim to recruit 312 participants in Sun Yat-sen Memorial Hospital, Guangzhou, China that meet the eligibility criteria.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: No Intervention: Observational CohortHistologically confirmed sbORN that meets the eligibility criteria. |
| Control | – | Other: No Intervention: Observational CohortHistologically confirmed NPC recurrence that meets the eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All populations that meet the eligibility criteria.
Key inclusion criteria (9 listed)
- Equal to or older than 18 years old.
- A history of histologically confirmed nonkeratinizing undifferentiated nasopharyngeal carcinoma.
- A history of radical radiotherapy at nasopharynx.
- Complete remission six months post radical radiotherapy according to RECIST 1.1.
- No evidence of distant metastasis upon recruitment.
Key exclusion criteria (2 listed)
- MRI artifacts or other factors that interfere radiological diagnosis and region of interest contouring.
- Suspected lesion is not confined to nasopharynx and skull-base.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention is scheduled for this observational study. | Other | Case, Control |
Primary outcome
Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Time frame: Baseline
Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Time frame: Baseline
12 secondary outcomes
Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Time frame: Baseline
Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Time frame: Baseline
F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Time frame: Baseline
Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Time frame: Baseline
Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model.
Time frame: Baseline
Sensitivity of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Time frame: Baseline
Specificity of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Time frame: Baseline
F1 score of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Time frame: Baseline
Positive predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Time frame: Baseline
Negative predictive value of the differential diagnosis of sbORN and NPC recurrence delivered by the radiologists.
Time frame: Baseline
Dice similarity coefficient of the MRI contouring between the deep-learning-based multimodal model and the radiologists.
Time frame: Baseline
Average surface distance of the MRI contouring between the deep-learning-based multimodal model and the radiologists.
Time frame: Baseline
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 1 Oct 2024.
Related trials for Nasopharyngeal Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingObservational study
The Clinical Application Value of CAIX-Targeted PET Hypoxia Imaging in Malignant Tumors
Nasopharyngeal Cancers, Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Pembrolizumab + MRGOO3 as Neoadjuvant in NPC
NPC, Locoregionally Advanced Nasopharyngeal Carcinoma
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.
1 site 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 Herpesvirus 4, Human, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site 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 9 inclusion and 2 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Xiang-Wei Kong, Ph.D. (0086-020-34071439, kongxw8@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve of the differential diagnosis of sbORN and NPC recurrence delivered by the deep-learning-based multimodal model. (time frame: Baseline). The study lists 2 primary outcomes in all. 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 1 Oct 2024.