Papillary Thyroid CancerNCT06286631
Prediction of Lymph Node Metastasis in Patients With Thyroid Malignancy by a New Scale
An observational study of Papillary Thyroid Cancer, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
The incidence of papillary thyroid cancer (PTC) has been on the rise in recent years, and 20%-50% of PTC patients will have lymph node metastasis. Lymph node involvement in PTC patients is usually related to the recurrence of PTC after surgery, and 30% of patients recur without lymph node dissection, with the risk of… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Papillary Thyroid Cancer
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 Oct 2026
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: From 2021 to 2023, 500 patients with previous papillary thyroid cancer surgery were selected at the Second Affiliated Hospital of Xi'an Jiaotong University for the quantitative rating scale, as well as 300 newly admitted papillary thyroid cancer patients for subsequent validation.
Who may be able to join
- Papillary thyroid cancer
- Conscious and able to communicate normally
- Age 16-80 years
Who cannot join
- Preoperative or postoperative pathology suggests other types of tumors, such as medullary carcinoma or undifferentiated carcinoma.
- Less than 16 years of age
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Yang Liu, doctor, 0086+029-13384986500, individualliu@163.com
About this study
Official title: Quantitative Rating Scale Based on Preoperative Prediction of Lymph Node Dissection in Patients With Thyroid Cancer
The incidence of papillary thyroid cancer (PTC) has been on the rise in recent years, and 20%-50% of PTC patients will have lymph node metastasis. Lymph node involvement in PTC patients is usually related to the recurrence of PTC after surgery, and 30% of patients recur without lymph node dissection, with the risk of central cervical lymph node metastasis being the greatest, so it seems to be a good choice to perform lymph node dissection on patients after thyroidectomy, but in fact, there are controversies at home and abroad as to whether to perform lymph node dissection or not. The 2021 Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of differentiated thyroid cancer state that prophylactic central lymph node dissection (PCND) may increase the incidence of postoperative complications, but due to the high metastatic rate of PTC and the ability of PCND to effectively prevent recurrence and reoperation, countries in the East Asian region perform prophylactic lymph node dissection on almost all patients with PTC. However, for more countries in Europe and the United States, performing PCND has become a non-essential, individualized option. The aim of this study is to collect multifactorial data from more than 1,000 patients who have undergone previous thyroidectomy from 2021 to 2023, and to develop a novel scoring scale that can be used to individualize patients' scores based on a variety of factors prior to surgery, so that patients can be more accurately predicted to have lymph node metastasis and need prophylactic lymph node dissection prior to surgery, and patients who do not need dissection can avoid surgery. For patients who do not need lymph node dissection, complications caused by surgery can be avoided, while for patients who do have lymph node metastasis, recurrence of their cancer can be prevented. This will change the status quo of not being able to accurately determine the actual situation through simple preoperative examination or performing prophylactic lymph node dissection for all PTC patients.
Read the detailed description
- Patient characteristics: the inclusion criteria were as follows:1. patients with papillary thyroid cancer;2. minimum age of 16 years old and maximum age of 80 years old. Exclusion criteria:1. age less than 16 years old;2. postoperative pathology suggesting that there are other types of tumors, such as medullary carcinoma or undifferentiated carcinoma. 2,.Data collection: Investigators collected multifactorial data on about 1000 patients who had undergone previous thyroidectomy from 2021-2023, including gender, height, age, weight, BMI, diameter of the tumor in the primary focus, tumor limitation in the primary focus, lymph node metastasis, and tumor invasion, preoperative ultrasonographic manifestations, preoperative laboratory results, pathological results, and genetic testing results. From these, the available data were screened and retained for analysis. 3.Data analysis: According to the retained data after screening, classical machine learning algorithms will be used for feature selection to select the factors with greater correlation with the results, and then with the help of data visualization, the specific quantitative relationship between each factor and the results will be determined according to the distribution of the available data, and the quantitative scoring table will be created. 4. Clinical validation: The completed quantitative rating scale investigators will be validated in the clinic. Investigators will use the scale to score new patients to assess whether participants need prophylactic lymph node dissection, and then evaluate the accuracy of the quantitative scale according to the intraoperative or postoperative situation.
- Conditions
- Papillary Thyroid Cancer
- Keywords
- Papillary Thyroid Cancer, pre-operative, Prophylactic lymph node dissection, lymphatic node transfer, Multi-factor data
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Past Medical Records Group | Sample size:500 Whether control group:No Name of exposure factor:papillary thyroid cancer Exposure factor type:Other Description of exposure factor:None | |
| Clinical Validation Group | Sample size:300 Whether control group:No Name of exposure factor:papillary thyroid cancer Exposure factor type:Other Description of exposure factor:None |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
The height indicator will summarize the data in "meters".
Measured: up to three years
Weight
The weight indicator will summarize data in "kilograms".
Measured: up to three years
Age
Age will be aggregated using "years" as the unit of measurement.
Measured: up to three years
Genders
Data will be summarized in terms of "male" and "female" as units of measurement.
Measured: up to three years
BMI
BMI will be summarized in "kg/m^2".
Measured: up to three years
Whether lymph node dissection was performed during previous surgery
Data will be summarized using "yes" or "no" for whether lymph node dissection was performed during previous surgery.
Measured: up to three years
Tumor Diameter Size
Tumor diameter size will be summarized in "millimeters".
Measured: up to three years
Tumor limitation of the primary focus
Tumor limitation of primary foci will be summarized using "single/multiple" and "unilateral/bilateral".
Measured: up to three years
Extratumoral invasion
Extra-tumor focal invasion will be summarized with a "yes" or "no" to the data.
Measured: up to three years
Pathologic lymph node metastasis
Pathological lymph node metastases will be summarized with "yes" or "no" data.
Measured: up to three years
Tumor cystic solidity on preoperative ultrasound
Pre-operative ultrasound tumor cysticity will be summarized as "cystic" or "solid".
Measured: up to three years
Preoperative ultrasound tumor echo intensity
Preoperative ultrasound tumor echo intensity will be summarized as "high echo" or "moderate echo" or "low echo" or "very low echo".
Measured: up to three years
Preoperative ultrasound tumor boundaries
Preoperative ultrasound tumor boundaries will be summarized as "clear" or "unclear".
Measured: up to three years
Preoperative ultrasound tumor for the presence of calcifications
Preoperative ultrasound tumors will be summarized with "yes" or "no" for the presence of calcifications.
Measured: up to three years
Preoperative ultrasound tumor aspect ratios
Preoperative ultrasound tumor aspect ratios will be summarized with ">1" or "<1" data
Measured: up to three years
Preoperative ultrasound for enlarged cervical lymph nodes
Preoperative ultrasound of cervical lymph nodes for enlargement will be summarized as "yes" or "no".
Measured: up to three years
TSH
The TSH indicator will summarize data in "mlU/L".
Measured: up to three years
TPOAb
The TPOAb indicator will summarize data in "lU/mL".
Measured: up to three years
TgAb
The TgAb indicator will summarize data in "lU/mL".
Measured: up to three years
Calcium
The Calcium indicator will summarize data in "mmol/L".
Measured: up to three years
B-raf gene mutation
B-raf mutations will be summarized as "wild type" or "mutant".
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 May 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid CancerStudies 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
- Other
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286631
- Sponsor's protocol ID
- Rating scale-202402
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Rating Scale Based on Preoperative Prediction of Lymph Node Dissection in Patients With Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06286631
- Acronym / sponsor ID
- Rating scale-202402
- Conditions
- Papillary Thyroid Cancer
- Keywords
- Papillary Thyroid Cancer, pre-operative, Prophylactic lymph node dissection, lymphatic node transfer, Multi-factor data
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 29 Feb 2024 (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.
The incidence of papillary thyroid cancer (PTC) has been on the rise in recent years, and 20%-50% of PTC patients will have lymph node metastasis. Lymph node involvement in PTC patients is usually related to the recurrence of PTC after surgery, and 30% of patients recur without lymph node dissection, with the risk of central cervical lymph node metastasis being the greatest, so it seems to be a good choice to perform lymph node dissection on patients after thyroidectomy, but in fact, there are controversies at home and abroad as to whether to perform lymph node dissection or not. The 2021 Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of differentiated thyroid cancer state that prophylactic central lymph node dissection (PCND) may increase the incidence of postoperative complications, but due to the high metastatic rate of PTC and the ability of PCND to effectively prevent recurrence and reoperation, countries in the East Asian region perform prophylactic lymph node dissection on almost all patients with PTC. However, for more countries in Europe and the United States, performing PCND has become a non-essential, individualized option. The aim of this study is to collect multifactorial data from more than 1,000 patients who have undergone previous thyroidectomy from 2021 to 2023, and to develop a novel scoring scale that can be used to individualize patients' scores based on a variety of factors prior to surgery, so that patients can be more accurately predicted to have lymph node metastasis and need prophylactic lymph node dissection prior to surgery, and patients who do not need dissection can avoid surgery. For patients who do not need lymph node dissection, complications caused by surgery can be avoided, while for patients who do have lymph node metastasis, recurrence of their cancer can be prevented. This will change the status quo of not being able to accurately determine the actual situation through simple preoperative examination or performing prophylactic lymph node dissection for all PTC patients.
Detailed description
- Patient characteristics: the inclusion criteria were as follows:1. patients with papillary thyroid cancer;2. minimum age of 16 years old and maximum age of 80 years old. Exclusion criteria:1. age less than 16 years old;2. postoperative pathology suggesting that there are other types of tumors, such as medullary carcinoma or undifferentiated carcinoma. 2,.Data collection: Investigators collected multifactorial data on about 1000 patients who had undergone previous thyroidectomy from 2021-2023, including gender, height, age, weight, BMI, diameter of the tumor in the primary focus, tumor limitation in the primary focus, lymph node metastasis, and tumor invasion, preoperative ultrasonographic manifestations, preoperative laboratory results, pathological results, and genetic testing results. From these, the available data were screened and retained for analysis. 3.Data analysis: According to the retained data after screening, classical machine learning algorithms will be used for feature selection to select the factors with greater correlation with the results, and then with the help of data visualization, the specific quantitative relationship between each factor and the results will be determined according to the distribution of the available data, and the quantitative scoring table will be created. 4. Clinical validation: The completed quantitative rating scale investigators will be validated in the clinic. Investigators will use the scale to score new patients to assess whether participants need prophylactic lymph node dissection, and then evaluate the accuracy of the quantitative scale according to the intraoperative or postoperative situation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Past Medical Records Group | – | –Sample size:500 Whether control group:No Name of exposure factor:papillary thyroid cancer Exposure factor type:Other Description of exposure factor:None |
| Clinical Validation Group | – | –Sample size:300 Whether control group:No Name of exposure factor:papillary thyroid cancer Exposure factor type:Other Description of exposure factor:None |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From 2021 to 2023, 500 patients with previous papillary thyroid cancer surgery were selected at the Second Affiliated Hospital of Xi'an Jiaotong University for the quantitative rating scale, as well as 300 newly admitted papillary thyroid cancer patients for subsequent validation.
Key inclusion criteria (3 listed)
- Papillary thyroid cancer
- Conscious and able to communicate normally
- Age 16-80 years
Key exclusion criteria (2 listed)
- Preoperative or postoperative pathology suggests other types of tumors, such as medullary carcinoma or undifferentiated carcinoma.
- Less than 16 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Height
Time frame: up to three years
The height indicator will summarize the data in "meters".
Weight
Time frame: up to three years
The weight indicator will summarize data in "kilograms".
Age
Time frame: up to three years
Age will be aggregated using "years" as the unit of measurement.
Genders
Time frame: up to three years
Data will be summarized in terms of "male" and "female" as units of measurement.
BMI
Time frame: up to three years
BMI will be summarized in "kg/m^2".
Whether lymph node dissection was performed during previous surgery
Time frame: up to three years
Data will be summarized using "yes" or "no" for whether lymph node dissection was performed during previous surgery.
Tumor Diameter Size
Time frame: up to three years
Tumor diameter size will be summarized in "millimeters".
Tumor limitation of the primary focus
Time frame: up to three years
Tumor limitation of primary foci will be summarized using "single/multiple" and "unilateral/bilateral".
Extratumoral invasion
Time frame: up to three years
Extra-tumor focal invasion will be summarized with a "yes" or "no" to the data.
Pathologic lymph node metastasis
Time frame: up to three years
Pathological lymph node metastases will be summarized with "yes" or "no" data.
Tumor cystic solidity on preoperative ultrasound
Time frame: up to three years
Pre-operative ultrasound tumor cysticity will be summarized as "cystic" or "solid".
Preoperative ultrasound tumor echo intensity
Time frame: up to three years
Preoperative ultrasound tumor echo intensity will be summarized as "high echo" or "moderate echo" or "low echo" or "very low echo".
Preoperative ultrasound tumor boundaries
Time frame: up to three years
Preoperative ultrasound tumor boundaries will be summarized as "clear" or "unclear".
Preoperative ultrasound tumor for the presence of calcifications
Time frame: up to three years
Preoperative ultrasound tumors will be summarized with "yes" or "no" for the presence of calcifications.
Preoperative ultrasound tumor aspect ratios
Time frame: up to three years
Preoperative ultrasound tumor aspect ratios will be summarized with ">1" or "<1" data
Preoperative ultrasound for enlarged cervical lymph nodes
Time frame: up to three years
Preoperative ultrasound of cervical lymph nodes for enlargement will be summarized as "yes" or "no".
TSH
Time frame: up to three years
The TSH indicator will summarize data in "mlU/L".
TPOAb
Time frame: up to three years
The TPOAb indicator will summarize data in "lU/mL".
TgAb
Time frame: up to three years
The TgAb indicator will summarize data in "lU/mL".
Calcium
Time frame: up to three years
The Calcium indicator will summarize data in "mmol/L".
B-raf gene mutation
Time frame: up to three years
B-raf mutations will be summarized as "wild type" or "mutant".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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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.
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 Papillary Thyroid Cancer, run by Second Affiliated Hospital of Xi'an Jiaotong 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: status not confirmed, as of the sponsor's last update on 29 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Liu, doctor (0086+029-13384986500, individualliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height (time frame: up to three years). The study lists 21 primary outcomes in all. 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 29 Feb 2024.