Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05191927 |
| Other study ID # |
NO.SYSEC-KY-KS-2021-180 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
August 1, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
1000 Patients who underwent total thyroidectomy or lobectomy and were diagnosed as PTC by
pathological examination between June 2014 and September 2019 in Sun Yat-sen Memorial
Hospital (Guangzhou, South China) and 200 patients in the First Affiliated Hospital of
Zhengzhou University (Zhengzhou, North China) from March 2019 to November 2020 were selected
as the subjects to construct the nomogram. 1000 patients were randomized at 7:3 and divided
into a training set and a verification set. Besides, 200 cases that met the inclusion and
exclusion criteria above-mentioned in the First affiliated Hospital of Zhengzhou University
were enrolled as a external verification set.
The following clinical features for each patient were obtained before surgery: gender, age,
occupation, complicated with autoimmune diseases (absent / present), history of radiation
exposure (absent / present), family history of thyroid cancer (absent / present), with other
tumors (absent / present) and preoperative laboratory examinations including neutrophil
count, lymphocyte count, platelet count, thyroid-stimulating hormone (TSH), free
triiodothyronine (fT3), free thyroxine (fT4), anti-thyroglobulin antibody (TgAb), thyroid
peroxidase antibody (TPOAb).
Preoperative US signatures of thyroid tumors were also included: distribution (unilateral /
bilateral), shape (regular / irregular), maximum diameter, number (single / multiple),
boundary（clear /heliclear / unclear), component (solid /cystic-solid), calcification (absent
/ microcalcification / macrocalcification), blood flow (absent / internal / annular),
cervical lymph node enlargement (absent / present).
A nomogram were established for predicting CLNM based on the universally available baseline
Characteristics of PTC patients at a tertiary hospital in South China and externally validate
it with data from North China. Odd ratios (ORs), 95% confidence interval (CI) and probability
values were obtained by logistic regression analysis. The area under the receiver operating
characteristic (ROC) curve (AUC) was calculated to evaluate the accuracy of the nomogram for
predicting CLNM. The calibration curve and Hosmer-Lemeshow tests were performed to evaluate
the calibration of the nomogram. The decision curve analysis (DCA) was applied to validate
clinical utility of the nomogram.
