Prediction of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma Based on Ultrasound and Cytological Images

NCT06399159 | Completed

• 1 other identifier: Review-2023-109
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Rising thyroid carcinoma rates, with papillary thyroid carcinoma (PTC) as the main type (85-90% of cases), often show early cervical lymph node spread. This increases the risk of PTC patients for recurrence and death. A new study's multimodal model fuses preoperative US and cytology images to better predict lymph node metastasis, aiming to improve treatment plans, reduce unnecessary surgeries, and enhance patient outcomes.

Conditions

Papillary Thyroid Carcinoma; Lymph Node Metastasis

Keywords

ultrasound; deep learning; cytology

Outcome Measures

Primary Outcomes (1)

• Presence or absence of lymph node metastasis

  All surgical specimens were subjected to paraffin-embedded histopathological examination，depending on the pathological findings, it is classified as the presence or absence of lymph node metastases.

  October 2024

Study Arms (2)

Cohort with Lymph Node Metastasis

Depending on the pathological findings, it is classified as the presence of lymph node metastases.

Procedure: Thyroidectomy and lymph node dissection

Cohort without Lymph Node Metastasis

Depending on the pathological findings, it is classified as the absence of lymph node metastases.

Procedure: Thyroidectomy and lymph node dissection

Interventions

Thyroidectomy and lymph node dissection PROCEDURE

All surgical specimens of thyroidectomy and lymph node dissection were subjected to paraffin-embedded histopathological examination, and postoperative were categorized as with cervical lymph node metastasis and without cervical lymph node metastasis.

Cohort with Lymph Node Metastasis; Cohort without Lymph Node Metastasis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with papillary thyroid cancer from ten hospitals in China

You may qualify if:

• Underwent thyroidectomy and bilateral lymph node dissection with pathological confirmation of PTC
• Completed US examination within one week before surgery
• Underwent preoperative us-guided FNAC
• Completed cytological images at 400× magnification under a microscope

You may not qualify if:

• Patients who underwent only unilateral thyroidectomy
• Patients with cervical lymph nodes shown on preoperative ultrasound

Sponsors & Collaborators

• Nanchong Central Hospital: lead

Study Sites (1)

Nanchong central hospital

Nanchong, Sichuan, 637000, China

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary; Lymphatic Metastasis

Interventions

Thyroidectomy; Lymph Node Excision

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Xiachuan Qin, MD

  Nanchong Central Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

CN (1)