NCT06463756

Brief Summary

This retrospective study was to develop and verify CT-based AI model to preoperatively predict the thyroid cartilage invasion of laryngeal cancer patients, so as to provide more accurate diagnosis and treatment basis for clinicians. In addition, the researchers investigated the prediction of survival outcomes of patients by the above optimal models.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

1.1 years

First QC Date

June 12, 2024

Last Update Submit

August 20, 2024

Conditions

Keywords

radiomicsdeep learning

Outcome Measures

Primary Outcomes (1)

  • Area under the curve, AUC

    Area under the curve(AUC) is a metric widely used in machine learning and medical research to evaluate the performance of models in binary classification problems. It reflects the ability of a model to identify true positives (True Positives) while avoiding falsely classifying negative examples as positive (False Positives).

    Through study completion, an average of 6 months

Secondary Outcomes (1)

  • Disease-Free-Survival, DFS

    The date of surgery and the occurrence of events such as disease progression, the date of the last follow-up, or death from any cause, and the follow-up time was at least 3 years

Study Arms (3)

training cohort

No interventions

Other: AI

internal validation cohort

No interventions

Other: AI

external validation cohort

No interventions

Other: AI

Interventions

AIOTHER

Radiomics extracts quantitative information from medical images to generate high-dimensional feature vectors for analysis. It aims to provide insights into disease processes and improve diagnosis. Deep learning utilizes neural networks with multiple layers to learn complex patterns from data. In medical imaging, it enables accurate and efficient analysis for disease detection and diagnosis.

Also known as: radiomics, deep learning
external validation cohortinternal validation cohorttraining cohort

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators collected patients with laryngeal carcinoma from two centers.

You may qualify if:

  • Availability of complete clinical data
  • Surgery-proven or biopsy-proven diagnosis of laryngeal squamous cell carcinoma
  • CT examination performed within 2 weeks before surgery

You may not qualify if:

  • Patients who received preoperative chemotherapy or radiation therapy
  • CT images with significant artifacts
  • Patients with tumor recurrence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms

Interventions

Deep Learning

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Machine LearningArtificial IntelligenceAlgorithmsMathematical ConceptsNeural Networks, Computer

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiology Department

Study Record Dates

First Submitted

June 12, 2024

First Posted

June 18, 2024

Study Start

August 13, 2023

Primary Completion

September 13, 2024

Study Completion

October 13, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

The clinical data are manually collected from the clinical case system; the CT image data are exported from the PACS system and anonymously stored on a separate data disk; and the image materials are collected and anonymously stored on a separate data disk.

Locations