Papillary Thyroid CarcinomaNCT06399159
Prediction of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma Based on Ultrasound and Cytological Images
An observational study of Papillary Thyroid Carcinoma and Lymph Node Metastasis, run by Nanchong Central Hospital at 1 site in China.
Trial summary
Rising thyroid carcinoma rates, with papillary thyroid carcinoma (PTC) as the main type (85-90% of cases), often show early cervical lymph node spread. This increases the risk of PTC patients for recurrence and death. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Papillary Thyroid Carcinoma, Lymph Node Metastasis
- What is being tested?
- Thyroidectomy and lymph node dissection
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Apr 2024
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with papillary thyroid cancer from ten hospitals in China
Who may be able to join
- Underwent thyroidectomy and bilateral lymph node dissection with pathological confirmation of PTC
- Completed US examination within one week before surgery
- Underwent preoperative us-guided FNAC
- Completed cytological images at 400× magnification under a microscope
Who cannot join
- Patients who underwent only unilateral thyroidectomy
- Patients with cervical lymph nodes shown on preoperative ultrasound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interpretable Multimodal Model Based on Cytology Ultrasound Noninvasively Predicts Lymph Node Metastasis in cN0 Papillary Thyroid Cancer
Rising thyroid carcinoma rates, with papillary thyroid carcinoma (PTC) as the main type (85-90% of cases), often show early cervical lymph node spread. This increases the risk of PTC patients for recurrence and death. A new study's multimodal model fuses preoperative US and cytology images to better predict lymph node metastasis, aiming to improve treatment plans, reduce unnecessary surgeries, and enhance patient outcomes.
Read the detailed description
Thyroid carcinoma incidence has been on the rise in recent years. Papillary thyroid carcinoma is the most prevalent type of differentiated thyroid carcinoma, accounting for 85% to 90% of malignant thyroid tumors. Despite its indolent nature, cervical lymph node metastasis is frequently observed at an early stage. Papillary thyroid carcinoma patients with cervical lymph node metastasis face an elevated risk of recurrence, distant metastasis, and mortality. Thus, non-invasive preoperative prediction of cervical lymph node metastasis is particularly vital for guiding treatment plans and prognostic. this study has developed a multimodal model integrating preoperative US images with cytological images of papillary thyroid carcinoma patients. The aim is to enhance the predictive accuracy for cervical lymph node metastasis, reduce unnecessary lymph node dissections, and provide real-time, precise guidance for determining the extent of surgical resection and prognostic assessment. This approach aims to optimize patient treatment strategies and enhance therapeutic outcomes.
- Conditions
- Papillary Thyroid Carcinoma, Lymph Node Metastasis
- Being tested
- Thyroidectomy and lymph node dissection
- Keywords
- ultrasound, deep learning, cytology
- Medical subject headings
- Thyroid Cancer, Papillary, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroidectomy and lymph node dissectionProcedure or surgery
All surgical specimens of thyroidectomy and lymph node dissection were subjected to paraffin-embedded histopathological examination, and postoperative were categorized as with cervical lymph node metastasis and without cervical lymph node metastasis.
| Study group | Role | What they receive |
|---|---|---|
| Cohort with Lymph Node Metastasis | Depending on the pathological findings, it is classified as the presence of lymph node metastases. Receives: Procedure: Thyroidectomy and lymph node dissection | |
| Cohort without Lymph Node Metastasis | Depending on the pathological findings, it is classified as the absence of lymph node metastases. Receives: Procedure: Thyroidectomy and lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of lymph node metastasis
All surgical specimens were subjected to paraffin-embedded histopathological examination，depending on the pathological findings, it is classified as the presence or absence of lymph node metastases.
Measured: October 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Sep 2023
- Primary completion1 Mar 2024
- 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 Papillary Thyroid 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
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xiachuan Qin,MD, Nanchong Central Hospital
- Investigators
- Xiachuan Qin, MD, Study chair, Nanchong Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399159
- Sponsor's protocol ID
- Review-2023-109
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interpretable Multimodal Model Based on Cytology Ultrasound Noninvasively Predicts Lymph Node Metastasis in cN0 Papillary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06399159
- Acronym / sponsor ID
- Review-2023-109
- Conditions
- Papillary Thyroid Carcinoma, Lymph Node Metastasis
- Keywords
- ultrasound, deep learning, cytology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 3 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.
Rising thyroid carcinoma rates, with papillary thyroid carcinoma (PTC) as the main type (85-90% of cases), often show early cervical lymph node spread. This increases the risk of PTC patients for recurrence and death. A new study's multimodal model fuses preoperative US and cytology images to better predict lymph node metastasis, aiming to improve treatment plans, reduce unnecessary surgeries, and enhance patient outcomes.
Detailed description
Thyroid carcinoma incidence has been on the rise in recent years. Papillary thyroid carcinoma is the most prevalent type of differentiated thyroid carcinoma, accounting for 85% to 90% of malignant thyroid tumors. Despite its indolent nature, cervical lymph node metastasis is frequently observed at an early stage. Papillary thyroid carcinoma patients with cervical lymph node metastasis face an elevated risk of recurrence, distant metastasis, and mortality. Thus, non-invasive preoperative prediction of cervical lymph node metastasis is particularly vital for guiding treatment plans and prognostic. this study has developed a multimodal model integrating preoperative US images with cytological images of papillary thyroid carcinoma patients. The aim is to enhance the predictive accuracy for cervical lymph node metastasis, reduce unnecessary lymph node dissections, and provide real-time, precise guidance for determining the extent of surgical resection and prognostic assessment. This approach aims to optimize patient treatment strategies and enhance therapeutic outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort with Lymph Node Metastasis | – | Procedure: Thyroidectomy and lymph node dissectionDepending on the pathological findings, it is classified as the presence of lymph node metastases. |
| Cohort without Lymph Node Metastasis | – | Procedure: Thyroidectomy and lymph node dissectionDepending on the pathological findings, it is classified as the absence of lymph node metastases. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with papillary thyroid cancer from ten hospitals in China
Key inclusion criteria (4 listed)
- Underwent thyroidectomy and bilateral lymph node dissection with pathological confirmation of PTC
- Completed US examination within one week before surgery
- Underwent preoperative us-guided FNAC
- Completed cytological images at 400× magnification under a microscope
Key exclusion criteria (2 listed)
- Patients who underwent only unilateral thyroidectomy
- Patients with cervical lymph nodes shown on preoperative ultrasound
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 |
|---|---|---|
| Thyroidectomy and lymph node dissectionAll surgical specimens of thyroidectomy and lymph node dissection were subjected to paraffin-embedded histopathological examination, and postoperative were categorized as with cervical lymph node metastasis and without cervical lymph node metastasis. | Procedure or surgery | Cohort with Lymph Node Metastasis, Cohort without Lymph Node Metastasis |
Primary outcome
Presence or absence of lymph node metastasis
Time frame: October 2024
All surgical specimens were subjected to paraffin-embedded histopathological examination，depending on the pathological findings, it is classified as the presence or absence of lymph node metastases.
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 22 May 2024.
- Individual participant dataSharing planned: Undecided
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Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
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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
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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.
Xiachuan Qin, MD study chair
Nanchong Central Hospital
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 Carcinoma and Lymph Node Metastasis, run by Nanchong Central Hospital 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 4 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 22 May 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?
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?
Presence or absence of lymph node metastasis (time frame: October 2024). 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 22 May 2024.