AI Models to Predict Thyroid Cartilage Invasion in Laryngeal Carcinoma

August 20, 2024 updated by: xinwei Chen, First Affiliated Hospital of Chongqing Medical University

CT-based Radiomics, Two-dimensional and Three-dimensional Deep Learning Models to Predict Thyroid Cartilage Invasion in Laryngeal Carcinoma: a Multicenter Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Laryngeal squamous cell carcinoma (LSCC), as one of the most common head and neck tumors, is the eighth leading cause of cancer-associated death worldwide. The treatment decisions has a profound impact on both tumor control and functional prognosis of LSCC patients. And these decisions are primarily based on tumor staging, with the invasion of the thyroid cartilage serving as a crucial determinant. Consequently, the presence of thyroid cartilage invasion indicates an advanced stage (T3 or T4) diagnosis for the LSCC patients. For patients without thyroid cartilage invasion, partial laryngectomy may be considered to preserve laryngeal function. However, for patients with advanced laryngeal carcinoma and thyroid cartilage invasion extending beyond the larynx, total laryngectomy is often necessary to completely remove the tumor and extend survival time. Therefore, accurate assessment of thyroid cartilage invasion is vital for treatment decision-making and prognosis evaluation for LSCC patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The investigators collected patients with laryngeal carcinoma from two centers.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who received preoperative chemotherapy or radiation therapy
  2. CT images with significant artifacts
  3. Patients with tumor recurrence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
training cohort
No interventions
Other: AI

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.

Other Names:
  • radiomics
  • deep learning
internal validation cohort
No interventions
Other: AI

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.

Other Names:
  • radiomics
  • deep learning
external validation cohort
No interventions
Other: AI

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.

Other Names:
  • radiomics
  • deep learning

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area under the curve, AUC
Time Frame: Through study completion, an average of 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease-Free-Survival, DFS
Time Frame: 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
Disease-Free Survival (DFS) refers to the time from the start of randomization (usually the starting point of a clinical trial) to the recurrence of the disease or death of the patient due to disease progression. DFS is an important clinical and statistical indicator used to evaluate the long-term effects of cancer treatment.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Chongqing Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nankai University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-Chenx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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