Thyroid Papillary CarcinomaNCT05191927
A Nomogram Model to Predict Central Lymphnode Metastasis in Thyroid Papillary Carcinoma
An observational study of Thyroid Papillary Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Papillary Carcinoma
- What is being tested?
- male
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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) .
Who may be able to join
- underwent TC operation for the first time
- confirmed as PTC by postoperative pathological examination
- underwent ipsilateral or bilateral CLND
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
About this study
Official title: A Nomogram Model to Predict Central Lymphnode Metastasis in Thyroid Papillary Carcinoma Suitable for Primary Hospitals
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.
Read the detailed 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.
- Conditions
- Thyroid Papillary Carcinoma
- Being tested
- male
- Keywords
- Thyroid Papillary Carcinoma, nomogram, central lymph node metastasis, predictor
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maleOther
Also called young, high platelet count, low TPOAb level, larger maximum diameter
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.
| Study group | Role | What they receive |
|---|---|---|
| female group | all are female | |
| male group | all are male Receives: Other: male |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multivariate logistic regression analysis
Multivariate logistic regression analysis were conducted to determine the potential nonlinear association between predictors and and the risk of CLNM.
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Papillary CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
- Investigators
- mingtong xu, professor, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191927
- Sponsor's protocol ID
- NO.SYSEC-KY-KS-2021-180
- Status last verified
- Dec 2021
- First submitted
- 17 Nov 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nomogram Model to Predict Central Lymphnode Metastasis in Thyroid Papillary Carcinoma Suitable for Primary Hospitals
- ClinicalTrials.gov ID
- NCT05191927
- Acronym / sponsor ID
- NO.SYSEC-KY-KS-2021-180
- Conditions
- Thyroid Papillary Carcinoma
- Keywords
- Thyroid Papillary Carcinoma, nomogram, central lymph node metastasis, predictor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| female group | – | –all are female |
| male group | – | Other: maleall are male |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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) .
Key inclusion criteria (3 listed)
- underwent TC operation for the first time
- confirmed as PTC by postoperative pathological examination
- underwent ipsilateral or bilateral CLND
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maleAlso: young, high platelet count, low TPOAb level, larger maximum diameterNine 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. | Other | male group |
Primary outcome
Multivariate logistic regression analysis
Time frame: 1day
Multivariate logistic regression analysis were conducted to determine the potential nonlinear association between predictors and and the risk of CLNM.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Thyroid Papillary Carcinoma
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruitingPhase 3
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy
Differentiated Thyroid Cancer
Not yet recruiting
Personalized Cancer Support (Thrive Track) to Manage the Emotional Needs of Young Adults With Thyroid, Melanoma and Testicular Cancer, PerCS-YA Trial
Differentiated Thyroid Gland Carcinoma, Malignant Testicular Neoplasm
Not yet recruitingObservational study
Bethesda Classification and Risk Stratification in Differentiated Thyroid Carcinoma
Differentiated Thyroid Carcinoma, Papillary Thyroid Carcinoma
Active, not recruitingPhase 1/2
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
Solid Tumors, CNS Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mingtong xu, professor study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Papillary Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multivariate logistic regression analysis (time frame: 1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.