10-year Retrospective Study of Oral and Maxillofacial Squamous Cell Carcinoma

NCT ID: NCT06366906

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

319 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-10

Study Completion Date

2024-02-10

Brief Summary

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Introduction: The incidence of occult cervical lymph node metastases (OCLNM) is reported to be 20%-30% in early-stage oral cancer and oropharyngeal cancer. There is a lack of an accurate diagnostic method to predict occult lymph node metastasis and to help surgeons make precise treatment decisions.

Aim: To construct and evaluate a preoperative diagnostic method to predict occult lymph node metastasis (OCLNM) in early-stage oral and oropharyngeal squamous cell carcinoma (OC and OP SCC) based on deep learning features (DLFs) and radiomics features.

Methods: A total of 319 patients diagnosed with early-stage OC or OP SCC were retrospectively enrolled and divided into training, test and external validation sets. Traditional radiomics features and DLFs were extracted from their MRI images. The least absolute shrinkage and selection operator (LASSO) analysis was employed to identify the most valuable features. Prediction models for OCLNM were developed using radiomics features and DLFs. The effectiveness of the models and their clinical applicability were evaluated using the area under the curve (AUC), decision curve analysis (DCA) and survival analysis.

Detailed Description

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Conditions

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HNSCC AI Radiomic MRI

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort A

Randomly (121 cases) divided as the training and test sets in a 7:3 ratio.

The Resnet50 deep learning (DL) model

Intervention Type DIAGNOSTIC_TEST

The predictive capability of the above Resnet50 deep learning (DL) model was validated in the test set. Based on the AUC and ACC, the best prediction model was identified. To explore the robust of the selected model, ROC analysis was performed the in the external validation set. Moreover, the Log-rank test was applied to evaluate the prognostic value of the model.

Cohort B

Segmented into two groups based on the batched collected, which were defined as external validation set1 (n = 68) and external validation set2 (n = 130)

The Resnet50 deep learning (DL) model

Intervention Type DIAGNOSTIC_TEST

The predictive capability of the above Resnet50 deep learning (DL) model was validated in the test set. Based on the AUC and ACC, the best prediction model was identified. To explore the robust of the selected model, ROC analysis was performed the in the external validation set. Moreover, the Log-rank test was applied to evaluate the prognostic value of the model.

Interventions

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The Resnet50 deep learning (DL) model

The predictive capability of the above Resnet50 deep learning (DL) model was validated in the test set. Based on the AUC and ACC, the best prediction model was identified. To explore the robust of the selected model, ROC analysis was performed the in the external validation set. Moreover, the Log-rank test was applied to evaluate the prognostic value of the model.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Pathologically confirmed, previously untreated oral and oropharyngeal squamous cell carcinoma with radical resection;
2. MRI examination was performed two weeks before surgery;
3. All patients with neck dissection and the status of regional lymph nodes was confirmed via pathological examination;
4. All patients had no clinical evidence of nodal involvement.

Exclusion Criteria

1. Other malignant tumor, such as adenoid cystic carcinoma;
2. a lack of complete MRI imaging or poor MRI imaging quality;
3. patients had undergone neck dissection or treated non-surgically;
4. patients with metastatic disease.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sun yat-sen memorial hospital

Guangzhou, Guangdong, China

Site Status

Sun yat-sun memorial hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SYSKY-2023-426-01

Identifier Type: -

Identifier Source: org_study_id

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