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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06399159
Other study ID # Review-2023-109
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date April 1, 2024

Study information

Verified date May 2024
Source Nanchong Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Thyroid carcinoma incidence has been on the rise in recent years. Papillary thyroid carcinoma is the most prevalent type of differentiated thyroid carcinoma, accounting for 85% to 90% of malignant thyroid tumors. Despite its indolent nature, cervical lymph node metastasis is frequently observed at an early stage. Papillary thyroid carcinoma patients with cervical lymph node metastasis face an elevated risk of recurrence, distant metastasis, and mortality. Thus, non-invasive preoperative prediction of cervical lymph node metastasis is particularly vital for guiding treatment plans and prognostic. this study has developed a multimodal model integrating preoperative US images with cytological images of papillary thyroid carcinoma patients. The aim is to enhance the predictive accuracy for cervical lymph node metastasis, reduce unnecessary lymph node dissections, and provide real-time, precise guidance for determining the extent of surgical resection and prognostic assessment. This approach aims to optimize patient treatment strategies and enhance therapeutic outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date April 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients who underwent only unilateral thyroidectomy - Patients with cervical lymph nodes shown on preoperative ultrasound

Study Design


Intervention

Procedure:
Thyroidectomy and lymph node dissection
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.

Locations

Country Name City State
China Nanchong central hospital Nanchong Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Nanchong Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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