NCT06638762

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

8 years

First QC Date

October 10, 2024

Last Update Submit

October 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oral squamous cell carcinoma Recurrence

    Oral squamous cell carcinoma recurred after surgery

    after surgery

Interventions

surgeryPROCEDURE

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Head and neck squamous cell carcinoma and underwent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

January 1, 2015

Primary Completion

December 31, 2022

Study Completion

September 1, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10