Cancer of Head and NeckNCT06638762
Multi-Site Pathological Images-Guided ViT for Oral Squamous Cell Carcinoma Recurrence Prediction
An observational study of Cancer of Head and Neck, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Background: Head and neck squamous cell carcinoma is one of the most common cancers. Postoperative recurrence is a risk factor for poor prognosis and decreased survival rate. There is a lag and passivity in the diagnosis and monitoring of postoperative recurrence in clinical diagnosis and treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 1,325 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Head and neck squamous cell carcinoma and underwent surgery
Inclusion Criteria:Head and neck squamous cell carcinoma and underwent surgery -
Exclusion Criteria:Head and neck squamous cell carcinoma and without underwent surgery
-
About this study
Background:
Head and neck squamous cell carcinoma is one of the most common cancers. Postoperative recurrence is a risk factor for poor prognosis and decreased survival rate. There is a lag and passivity in the diagnosis and monitoring of postoperative recurrence in clinical diagnosis and treatment. The application of artificial intelligence to explore and develop a model for predicting postoperative recurrence of oral squamous cell carcinoma is expected to solve clinical difficulties and guide the formulation of postoperative monitoring and diagnosis and treatment plans.
Read more
Materials and Methods: We recruited patients diagnosed with oral squamous cell carcinoma who had received surgical treatment, collected patient follow-up information and postoperative pathological images, enhanced and standardized pathological images, and extracted pathological features through visual transformation model (ViT). The features of pathological images were fused into a multi-layer perceptron model (MLP) for training, verification and testing, and the predictive performance of the model was evaluated by various indexes.
Results:
Among the 1325 patients enrolled, 275 relapsed, accounting for 20.8%. The optimized ViT-Small model has a validation AUC of 94.79% (90% accuracy) and a test AUC of 95.68% (91.5% accuracy), and outperforms other models on both validation and test sets.
Conclusion:
ViT-Small model have high predictive performance, which is expected to predict postoperative recurrence, guide the formulation of clinical diagnosis and treatment plan.
Read the detailed description
As the most common tumor in the world, the five-year relative survival rate of head and neck squamous cell carcinoma is about 68%, and the five-year relative survival rate of distant tumors is 40%. More than 60% of patients were diagnosed as locally advanced, the rate of postoperative recurrence was as high as 40%, and the five-year relative survival rate was less than 50%. Tumor metastasis and postoperative recurrence were risk factors for poor prognosis and decreased survival rate, and tumor recurrence occurred almost within 2 years after surgery. The treatment of locally advanced patients often includes postoperative chemoradiotherapy, immunotherapy, etc., and the treatment of early patients is often mainly surgical resection. The problem of over-treatment and missed diagnosis and treatment may occur when guiding postoperative treatment according to clinical or pathological stages, and the risk judgment of postoperative recurrence lacks objective basis and quantitative standard.
In clinical diagnosis and treatment, whether adjuvant treatment is needed after surgery should be considered in combination with the risk of recurrence and pathological risk factors. For the monitoring and diagnosis of postoperative recurrence, regular follow-up of patients, imaging and pathological examination and clinical experience judgment of the attending physician are often required, which has lag and passivity. Prediction of postoperative recurrence, optimization of follow-up plan and timely development of personalized postoperative treatment will effectively reduce postoperative recurrence.
The application of artificial intelligence in the medical field has provided non-invasive diagnosis and support for the diagnosis and screening of oral cancer. Previously, we deeply learned the clinical diagnosis and treatment information and follow-up data of oral cancer patients to establish a model to predict postoperative recurrence of oral cancer. MLP model can predict postoperative recurrence of oral cancer to a certain extent. In order to focus on postoperative pathology, this study establishes a postoperative recurrence prediction model by deep learning of pathological risk factors, which is expected to improve the prediction efficiency and simplify the process, thus guiding the monitoring plan.Deep learning pathological images and the establishment of postoperative recurrence prediction model of oral squamous cell carcinoma through digital pathology have high predictive performance, which is expected to predict postoperative recurrence, guide the formulation of clinical diagnosis and treatment plan, develop personalized treatment plan for patients, reduce postoperative recurrence and improve survival rate.
- Conditions
- Cancer of Head and Neck
- Being tested
- surgery
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
We recruited patients diagnosed with oral squamous cell carcinoma who had received surgical treatment, collected patient follow-up information and postoperative pathological images, enhanced and standardized pathological images, and extracted pathological features through visual transformation model.
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral squamous cell carcinoma Recurrence
Oral squamous cell carcinoma recurred after surgery
Measured: after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2015
- Primary completion31 Dec 2022
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 1,325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638762
- Sponsor's protocol ID
- SYSKY-2024-440-01
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Site Pathological Images-Guided ViT for Oral Squamous Cell Carcinoma Recurrence Prediction
- ClinicalTrials.gov ID
- NCT06638762
- Acronym / sponsor ID
- SYSKY-2024-440-01
- Conditions
- Cancer of Head and Neck
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,325 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 15 Oct 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.
Background:
Head and neck squamous cell carcinoma is one of the most common cancers. Postoperative recurrence is a risk factor for poor prognosis and decreased survival rate. There is a lag and passivity in the diagnosis and monitoring of postoperative recurrence in clinical diagnosis and treatment. The application of artificial intelligence to explore and develop a model for predicting postoperative recurrence of oral squamous cell carcinoma is expected to solve clinical difficulties and guide the formulation of postoperative monitoring and diagnosis and treatment plans.
Materials and Methods: We recruited patients diagnosed with oral squamous cell carcinoma who had received surgical treatment, collected patient follow-up information and postoperative pathological images, enhanced and standardized pathological images, and extracted pathological features through visual transformation model (ViT). The features of pathological images were fused into a multi-layer perceptron model (MLP) for training, verification and testing, and the predictive performance of the model was evaluated by various indexes.
Results:
Among the 1325 patients enrolled, 275 relapsed, accounting for 20.8%. The optimized ViT-Small model has a validation AUC of 94.79% (90% accuracy) and a test AUC of 95.68% (91.5% accuracy), and outperforms other models on both validation and test sets.
Conclusion:
ViT-Small model have high predictive performance, which is expected to predict postoperative recurrence, guide the formulation of clinical diagnosis and treatment plan.
Detailed description
As the most common tumor in the world, the five-year relative survival rate of head and neck squamous cell carcinoma is about 68%, and the five-year relative survival rate of distant tumors is 40%. More than 60% of patients were diagnosed as locally advanced, the rate of postoperative recurrence was as high as 40%, and the five-year relative survival rate was less than 50%. Tumor metastasis and postoperative recurrence were risk factors for poor prognosis and decreased survival rate, and tumor recurrence occurred almost within 2 years after surgery. The treatment of locally advanced patients often includes postoperative chemoradiotherapy, immunotherapy, etc., and the treatment of early patients is often mainly surgical resection. The problem of over-treatment and missed diagnosis and treatment may occur when guiding postoperative treatment according to clinical or pathological stages, and the risk judgment of postoperative recurrence lacks objective basis and quantitative standard.
In clinical diagnosis and treatment, whether adjuvant treatment is needed after surgery should be considered in combination with the risk of recurrence and pathological risk factors. For the monitoring and diagnosis of postoperative recurrence, regular follow-up of patients, imaging and pathological examination and clinical experience judgment of the attending physician are often required, which has lag and passivity. Prediction of postoperative recurrence, optimization of follow-up plan and timely development of personalized postoperative treatment will effectively reduce postoperative recurrence.
The application of artificial intelligence in the medical field has provided non-invasive diagnosis and support for the diagnosis and screening of oral cancer. Previously, we deeply learned the clinical diagnosis and treatment information and follow-up data of oral cancer patients to establish a model to predict postoperative recurrence of oral cancer. MLP model can predict postoperative recurrence of oral cancer to a certain extent. In order to focus on postoperative pathology, this study establishes a postoperative recurrence prediction model by deep learning of pathological risk factors, which is expected to improve the prediction efficiency and simplify the process, thus guiding the monitoring plan.Deep learning pathological images and the establishment of postoperative recurrence prediction model of oral squamous cell carcinoma through digital pathology have high predictive performance, which is expected to predict postoperative recurrence, guide the formulation of clinical diagnosis and treatment plan, develop personalized treatment plan for patients, reduce postoperative recurrence and improve survival rate.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Head and neck squamous cell carcinoma and underwent surgery
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 |
|---|---|---|
| surgeryWe recruited patients diagnosed with oral squamous cell carcinoma who had received surgical treatment, collected patient follow-up information and postoperative pathological images, enhanced and standardized pathological images, and extracted pathological features through visual transformation model. | Procedure or surgery | – |
Primary outcome
Oral squamous cell carcinoma Recurrence
Time frame: after surgery
Oral squamous cell carcinoma recurred after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Head and Neck, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral squamous cell carcinoma Recurrence (time frame: after surgery). 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 15 Oct 2024.