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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

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.

  1. 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.

  1. First posted15 Oct 2024
  2. Study start1 Jan 2015
  3. Primary completion31 Dec 2022
  4. Study completion1 Sep 2024

Resources

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)
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

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.

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