Thyroid CancerNCT06423105
Influencing Factors and Prediction Model of False-negative Central Lymph Nodes in Thyroid Cancer Patients
An observational study of Thyroid Cancer, run by Ningning Ren.
Trial summary
The problem of false-negative lymph nodes in the central region (CLN) refers to the inability to detect lymph nodes (LN) metastasis during preoperative ultrasound examination but is confirmed by surgical and postoperative pathological examination. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer
- How many people
- 6,369 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Apr 2024
- How long will I take part?
- 5 Years
- 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: This study collected 6369 patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital between January 2013 and December 2023, who were diagnosed with TC through postoperative pathology.
Who may be able to join
- All cases are new cases of thyroid cancer.
- All clinical data and research materials of the cases are complete.
- All cases underwent preoperative thyroid and neck lymph node examinations by the Ultrasound Department of Shandong Provincial Hospital.
- All cases showed no swelling in the central lymph node status on preoperative ultrasound.
- All cases underwent initial surgical treatment.
- All cases were diagnosed with thyroid cancer through postoperative pathological examination.
Who cannot join
- Except for cases of recurrence.
- Cases with incomplete clinical data and research materials are excluded.
- Cases that have not undergone thyroid and neck lymph node examination by the ultrasound department of Shandong Provincial Hospital before surgery are excluded.
- Cases with enlarged lymph nodes in the central thyroid region indicated by preoperative ultrasound are excluded.
- Excluding cases of secondary surgery.
- Cases with postoperative pathological diagnosis of benign thyroid tumors are excluded.
About this study
Official title: Influencing Factors and Prediction Model of False-negative Central Lymph Nodes in Thyroid Cancer Patients: a Cohort Study
The problem of false-negative lymph nodes in the central region (CLN) refers to the inability to detect lymph nodes (LN) metastasis during preoperative ultrasound examination but is confirmed by surgical and postoperative pathological examination. According to this study, the false-negative rate of CLN of patients with TC was relatively high at approximately 71.7%. The high proportion of false-negatives indicates limitations in the sensitivity of ultrasound examination, especially for detecting small LN or small metastases. The presence of false-negative CLN directly affects clinical practice. First, it may lead to insufficient selection of treatment strategies for patients with TC, thereby affecting their prognosis. Second, such false-negative results may lead surgeons to overly trust ultrasound examination during preoperative evaluation, neglecting the importance of comprehensive clinical information, and thus affecting the formulation of treatment plans. This study aimed to explore the factors influencing false-negative CLN through a cohort study and to establish a predictive model.
Read the detailed description
Setting and Population This study collected 6369 patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital between January 2013 and December 2023, who were diagnosed with TC through postoperative pathology. (SDC, Figure 1) All patients included in the study signed a written informed consent form before surgery. Ethical approval for this study (NO.SWYX2024-225) was provided by the Ethical Committee of Shandong Provincial Hospital, Jinan, China on 15 April 2024. According to the relevant literature, the criteria for identifying abnormal cervical LN under ultrasound are: disappearance of the LN hilum structure or abnormalities in the skin and medulla, LN becoming round or having an increased aspect ratio, microcalcifications in the LN, cystic changes present in LN, and abnormal blood flow signals in LN.17 The inclusion and exclusion criteria are: all cases are newly diagnosed TC cases; all cases underwent preoperative thyroid and neck LN examinations by the Ultrasound Department of Shandong Provincial Hospital; all cases underwent thyroid surgery for the first time; all cases were diagnosed with TC through postoperative pathological examination; excluding cases of other combined tumors or major diseases. This study used the postoperative paraffin pathology results as the gold standard for diagnostic testing. All ultrasound examinations were performed by two ultrasound physicians. When two ultrasound physicians had different opinions, a third senior ultrasound physician was requested to assist in the evaluation.
Data Collection After obtaining written consent, we recorded the patient\'s relevant information in detail and followed up on the patient\'s postoperative paraffin pathology results. The collected and organized items included: 1) sex, age, and past medical history; 2) preoperative ultrasound information; 3) preoperative fine-needle biopsy information; 4) surgical information; 5) postoperative pathological information; and 6) immunohistochemical information.
Statistical Analysis This study first analyzed the baseline data of the included patients and obtained descriptive data on the current status of patients with TC. (Table 1) This study also analyzed the efficacy of ultrasound and fine-needle aspiration (FNA) for the evaluation of cervical LN. (Table 2) Subsequently, analysis was conducted on 52 factors that may cause false-negative CLN of TC. (Table 3) A total of 16 statistically significant influencing factors were identified. (Table 4) To construct a predictive model for the occurrence of false-negative CLN of the thyroid gland, we selected five preoperative influencing factors with predictive significance from eight preoperative influencing factors and drew a forest chart for data visualization and outcome prediction.
This study was analyzed using IBM SPSS 29.0 software. Quantitative data are represented by mean ± standard deviation when it follows a normal distribution and homogeneity of variance, and an independent sample t-test is used for comparison between the two groups; the median (P25, P75) is used to represent non-normal distributions, and a non-parametric Mann-Whitney test is used for comparison between the two groups. Qualitative data were expressed as percentages (%), and intergroup comparisons were conducted using the chi-square or Fisher\'s exact test. Variables with statistical significance in the univariate analysis and those professionally considered to have an impact on the outcome were included in the logistic regression model to explore the independent factors influencing the outcome. The test level P was set at 0.05. A forest map was drawn using Graphpad Prism 10.12 software, and a column chart and credibility analysis were drawn using R Studio 4.3 software.
- Conditions
- Thyroid Cancer
- Keywords
- thyroid cancer, central lymph nodes, false negative
- Medical subject headings
- Thyroid Neoplasms
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 |
|---|---|---|
| false negative | This article defines cases that preoperative ultrasound indicates no suspicious malignant enlargement of central lymph nodes and postoperative paraffin pathology indicates the presence of metastatic cancer in central lymph nodes as false-negative cases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological results
This article defines cases that preoperative ultrasound indicates no suspicious malignant enlargement of central lymph nodes and postoperative paraffin pathology indicates the presence of metastatic cancer in central lymph nodes as false-negative cases.
Measured: From enrollment to the end of treatment at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Jan 2013
- Primary completion31 Dec 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 6,369 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ningning Ren
- Sponsor type
- Other government
- Collaborators
- Shandong University
- Responsible party
- Sponsor-investigator, Ningning Ren, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423105
- Sponsor's protocol ID
- NO.SWYX2024-225
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: for privacy
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Factors and Prediction Model of False-negative Central Lymph Nodes in Thyroid Cancer Patients: a Cohort Study
- ClinicalTrials.gov ID
- NCT06423105
- Acronym / sponsor ID
- NO.SWYX2024-225
- Conditions
- Thyroid Cancer
- Keywords
- thyroid cancer, central lymph nodes, false negative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,369 participants (actual)
- Lead sponsor
- Ningning RenOther government
- Collaborators
- Shandong University
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 21 May 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 problem of false-negative lymph nodes in the central region (CLN) refers to the inability to detect lymph nodes (LN) metastasis during preoperative ultrasound examination but is confirmed by surgical and postoperative pathological examination. According to this study, the false-negative rate of CLN of patients with TC was relatively high at approximately 71.7%. The high proportion of false-negatives indicates limitations in the sensitivity of ultrasound examination, especially for detecting small LN or small metastases. The presence of false-negative CLN directly affects clinical practice. First, it may lead to insufficient selection of treatment strategies for patients with TC, thereby affecting their prognosis. Second, such false-negative results may lead surgeons to overly trust ultrasound examination during preoperative evaluation, neglecting the importance of comprehensive clinical information, and thus affecting the formulation of treatment plans. This study aimed to explore the factors influencing false-negative CLN through a cohort study and to establish a predictive model.
Detailed description
Setting and Population This study collected 6369 patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital between January 2013 and December 2023, who were diagnosed with TC through postoperative pathology. (SDC, Figure 1) All patients included in the study signed a written informed consent form before surgery. Ethical approval for this study (NO.SWYX2024-225) was provided by the Ethical Committee of Shandong Provincial Hospital, Jinan, China on 15 April 2024. According to the relevant literature, the criteria for identifying abnormal cervical LN under ultrasound are: disappearance of the LN hilum structure or abnormalities in the skin and medulla, LN becoming round or having an increased aspect ratio, microcalcifications in the LN, cystic changes present in LN, and abnormal blood flow signals in LN.17 The inclusion and exclusion criteria are: all cases are newly diagnosed TC cases; all cases underwent preoperative thyroid and neck LN examinations by the Ultrasound Department of Shandong Provincial Hospital; all cases underwent thyroid surgery for the first time; all cases were diagnosed with TC through postoperative pathological examination; excluding cases of other combined tumors or major diseases. This study used the postoperative paraffin pathology results as the gold standard for diagnostic testing. All ultrasound examinations were performed by two ultrasound physicians. When two ultrasound physicians had different opinions, a third senior ultrasound physician was requested to assist in the evaluation.
Data Collection After obtaining written consent, we recorded the patient\'s relevant information in detail and followed up on the patient\'s postoperative paraffin pathology results. The collected and organized items included: 1) sex, age, and past medical history; 2) preoperative ultrasound information; 3) preoperative fine-needle biopsy information; 4) surgical information; 5) postoperative pathological information; and 6) immunohistochemical information.
Statistical Analysis This study first analyzed the baseline data of the included patients and obtained descriptive data on the current status of patients with TC. (Table 1) This study also analyzed the efficacy of ultrasound and fine-needle aspiration (FNA) for the evaluation of cervical LN. (Table 2) Subsequently, analysis was conducted on 52 factors that may cause false-negative CLN of TC. (Table 3) A total of 16 statistically significant influencing factors were identified. (Table 4) To construct a predictive model for the occurrence of false-negative CLN of the thyroid gland, we selected five preoperative influencing factors with predictive significance from eight preoperative influencing factors and drew a forest chart for data visualization and outcome prediction.
This study was analyzed using IBM SPSS 29.0 software. Quantitative data are represented by mean ± standard deviation when it follows a normal distribution and homogeneity of variance, and an independent sample t-test is used for comparison between the two groups; the median (P25, P75) is used to represent non-normal distributions, and a non-parametric Mann-Whitney test is used for comparison between the two groups. Qualitative data were expressed as percentages (%), and intergroup comparisons were conducted using the chi-square or Fisher\'s exact test. Variables with statistical significance in the univariate analysis and those professionally considered to have an impact on the outcome were included in the logistic regression model to explore the independent factors influencing the outcome. The test level P was set at 0.05. A forest map was drawn using Graphpad Prism 10.12 software, and a column chart and credibility analysis were drawn using R Studio 4.3 software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| false negative | – | –This article defines cases that preoperative ultrasound indicates no suspicious malignant enlargement of central lymph nodes and postoperative paraffin pathology indicates the presence of metastatic cancer in central lymph nodes as false-negative cases. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study collected 6369 patients admitted to the Breast and Thyroid Surgery Department of Shandong Provincial Hospital between January 2013 and December 2023, who were diagnosed with TC through postoperative pathology.
Key inclusion criteria (6 listed)
- All cases are new cases of thyroid cancer.
- All clinical data and research materials of the cases are complete.
- All cases underwent preoperative thyroid and neck lymph node examinations by the Ultrasound Department of Shandong Provincial Hospital.
- All cases showed no swelling in the central lymph node status on preoperative ultrasound.
- All cases underwent initial surgical treatment.
Key exclusion criteria (6 listed)
- Except for cases of recurrence.
- Cases with incomplete clinical data and research materials are excluded.
- Cases that have not undergone thyroid and neck lymph node examination by the ultrasound department of Shandong Provincial Hospital before surgery are excluded.
- Cases with enlarged lymph nodes in the central thyroid region indicated by preoperative ultrasound are excluded.
- Excluding cases of secondary surgery.
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
Pathological results
Time frame: From enrollment to the end of treatment at 5 years
This article defines cases that preoperative ultrasound indicates no suspicious malignant enlargement of central lymph nodes and postoperative paraffin pathology indicates the presence of metastatic cancer in central lymph nodes as false-negative cases.
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 23 May 2024.
- Individual participant dataSharing planned: No. for privacy
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by Ningning Ren.
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 6 inclusion and 6 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 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Pathological results (time frame: From enrollment to the end of treatment at 5 years). 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 23 May 2024.