Clinical trial NCT06463756: AI Models to Predict Thyroid Cartilage Invasion in Laryngeal Carcinoma
Official title: CT-based Radiomics, Two-dimensional and Three-dimensional Deep Learning Models to Predict Thyroid Cartilage Invasion in Laryngeal Carcinoma: a Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Laryngeal Carcinoma
Thyroid Cartilage
Keywords: radiomics
deep learning
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Nankai University
First posted: 2024-06-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators collected patients with laryngeal carcinoma from two centers.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under the curve, AUC
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Disease-Free-Survival, DFS
timeFrame: 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
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
References: