A Nomogram Model to Predict Central Lymphnode Metastasis in Thyroid Papillary Carcinoma

NCT05191927 | Completed

• 1 other identifier: NO.SYSEC-KY-KS-2021-180
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

To establish and validate a suitable and practical nomogram for primary hospitals to predict the risk of central lymph node metastasis (CLNM) among thyroid papillary carcinoma (PTC) patients based on clinical and ultrasound characteristics among Chinese population，1000 PTC patients were retrospectively reviewed who underwent bilateral thyroidectomy or lobectomy plus central lymph node dissection（CLND） between June 2014 and September 2019 in Sun Yat-sen Memorial Hospital (Guangzhou, South China), and then LASSO regression analysis was performed to screen out the possible predictors. Another 200 PTC patients from the First Affiliated Hospital of Zhengzhou University (Zhengzhou, North China) who underwent bilateral thyroidectomy or lobectomy plus CLND between March 2019 and November 2020 were enrolled to construct the nomogram. The area under the receiver operating characteristic (ROC) curves (AUC), calibration curves and decision curve analysis (DCA) were used to evaluate the nomogram.

Conditions

Thyroid Papillary Carcinoma

Keywords

Thyroid Papillary Carcinoma; nomogram; central lymph node metastasis; predictor

Outcome Measures

Primary Outcomes (1)

• Multivariate logistic regression analysis

  Multivariate logistic regression analysis were conducted to determine the potential nonlinear association between predictors and and the risk of CLNM.

  1day

Study Arms (2)

female group

all are female

male group

all are male

Other: male

Interventions

male OTHER

Nine preoperative predictors were identified for the nomogram: gender, age, platelet counts, TPOAb level and US signatures including maximum diameter, boundary, component, calcification and cervical lymph node enlargement.

Also known as: young, high platelet count, low TPOAb level, larger maximum diameter, unclear boundary, solidity, calcification, cervical lymph node enlargement

male group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent total thyroidectomy or lobectomy and were diagnosed as PTC by pathological examination in Sun Yat-sen Memorial Hospital (Guangzhou, South China) and in the First Affiliated Hospital of Zhengzhou University (Zhengzhou, North China) .

You may qualify if:

• underwent TC operation for the first time
• confirmed as PTC by postoperative pathological examination
• underwent ipsilateral or bilateral CLND

You may not qualify if:

• complicated with other subtypes of TC or thyroid metastatic cancer
• received preoperative interventional therapy (such as radiofrequency and microwave therapy) or head and neck radiotherapy

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Interventions

Calcification, Physiologic

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

Intervention Hierarchy (Ancestors)

Biomineralization; Growth and Development; Physiological Phenomena; Bone Development; Musculoskeletal Development; Organogenesis; Embryonic and Fetal Development; Morphogenesis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• mingtong xu, professor

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: January 14, 2022
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: August 1, 2021
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)