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NCT06366906Completed

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

Clinicopathological and Prognostic Analysis of Oral and Maxillofacial Squamous Cell Carcinoma: a Single-center 10-year Retrospective Study

Source: ClinicalTrials.gov · Last updated 16 Apr 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
319 (actual)
First submitted
19 Mar 2024
Start date
May 2023
Primary completion date
Feb 2024
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NCT number
NCT06366906

What you commit to

  • Study type: Observational
  • Participants enrolled: 319
  • From May 2023 to the primary completion date, Feb 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Other malignant tumor, such as adenoid cystic carcinoma;
  • patients with metastatic disease.

Other

  • a lack of complete MRI imaging or poor MRI imaging quality;
  • patients had undergone neck dissection or treated non-surgically;

Who the study is looking for

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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen Memorial Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Sun yat-sun memorial hospital
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.