Papillary Thyroid CarcinomaNCT06725628
Multiomics Study of Biological Behavior of Lymph Node Metastasis in Papillary Thyroid Carcinoma
An observational study of Papillary Thyroid Carcinoma and Lymph Node Cancer Metastatic, run by Tianhan Zhou.
Trial summary
Establish a predictive model for assessing neck lymph node metastasis of papillary thyroid carcinoma based on metabolomics, proteomics, and imaging omics data, exploring an ideal protocal for the precise diagnosis and treatment of papillary thyroid carcinoma." Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Papillary Thyroid Carcinoma, Lymph Node Cancer Metastatic
- What is being tested?
- Thy_CLNM_multi_omics
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: PTC patients underwent surgery in Hangzhou Traditional Chinese Medical Hospital
Who may be able to join
- Pathological confirmation of PTC.
- Patients who underwent primary surgery accompanied by central neck lymph node dissection.
- Tumors measuring less than 2 cm in diameter.
- Postoperative pathological reports including detailed information on the number of lymph nodes dissected and the number of metastatic lymph nodes.
- Availability of comprehensive preoperative thyroid ultrasound images for analysis.
Who cannot join
- Postoperative pathological diagnosis indicating sub-types of PTC.
- Tumor invasion into adjacent anatomic structures such as the sternothyroid muscle, surrounding soft tissues, trachea, esophagus, or laryngeal nerve.
- History of neck trauma, previous tumor surgery, or adjuvant chemoradiotherapy.
- Fewer than three lymph nodes dissected during surgery.
- Concurrent acute inflammatory conditions or other hematologic disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Establish a predictive model for assessing neck lymph node metastasis of papillary thyroid carcinoma based on metabolomics, proteomics, and imaging omics data, exploring an ideal protocal for the precise diagnosis and treatment of papillary thyroid carcinoma."
Read the detailed description
This study is a multicenter, observational cohort study aimed at assessing the accuracy and effectiveness of the ThyMPR-CLNM multi-omics model in predicting CLNM in patients diagnosed with stage T1 PTC. The design incorporates the following critical components:
The study enrolled 2000 patients diagnosed with stage T1 PTC from Hangzhou Traditional Chinese Medical Hospital, affiliated with Zhejiang Chinese Medical University, between Dec.2024 and Dec.2026. Fresh frozen tumor tissue, serum samples, and preoperative ultrasound images were collected from participants. These samples were utilized for comprehensive multi-omics analyses, including metabolomic and proteomic profiling, as well as ultrasound radiomic feature extraction. To minimize selection bias and balance covariates, propensity score matching was performed in two rounds, establishing a discovery set and a validation set with matched groups based on the propensity scores calculated through logistic regression. This ensured comparable groups for subsequent analyses. The study involved analyzing the collected samples through advanced techniques such as liquid chromatography-mass spectrometry (LC-MS) for metabolomic and proteomic analyses, and Pyradiomics for extracting radiomics features from ultrasound images. Differentially expressed metabolites, proteins, and radiomic features were identified and integrated for the development of the ThyMPR-CLNM prediction model. The Least Absolute Shrinkage and Selection Operator (LASSO) regression technique was utilized to construct the ThyMPR-CLNM model based on identified features from the multi-omics analyses. The model's performance was subsequently validated using an independent dataset. Statistical evaluations were performed using R software to determine the model's accuracy, sensitivity, specificity, and AUC values. Comparisons with conventional diagnostic methods were conducted to highlight the ThyMPR-CLNM model's advantages.
- Being tested
- Thy_CLNM_multi_omics
- 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.
Thy_CLNM_multi_omicsDiagnostic test
Surgery
| Study group | Role | What they receive |
|---|---|---|
| LNM group and NLNM group | The primary objective of this study is to evaluate the accuracy of the ThyMPR-CLNM model in predicting central lymph node metastasis (CLNM) in patients with stage T1 papillary thyroid carcinoma (PTC). Receives: Diagnostic Test: Thy_CLNM_multi_omics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node metastasis status
Patients with thyroid cancer undergo thyroid cancer radical surgery according to the guidelines, with pathological results including the number of lymph node metastases and metastasis status, based on the final pathological diagnosis.
Measured: Record lymph node metastasis status until the end of the surgery, followed by a one-year follow-up until the conclusion of the study.
Secondary outcomes (1)
Surgical complications and postoperative recurrence
Hemorrhage，Infection，Recurrent laryngeal nerve injury，Hypothyroidism，Other related surgical complications and Recurrence status
Measured: Record surgical complications until the end of the surgery, followed by a one-year follow-up until the conclusion of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
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
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tianhan Zhou
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Tianhan Zhou, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725628
- Sponsor's protocol ID
- 2022KY153-CX1
- Other IDs
- 2022ZA119
- Status last verified
- Dec 2024
- First submitted
- 22 Nov 2024
- Last updated
- 10 Dec 2024
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiomics Study of Biological Behavior of Lymph Node Metastasis in Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT06725628
- Acronym / sponsor ID
- 2022KY153-CX1
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tianhan ZhouOther government
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 10 Dec 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.
Establish a predictive model for assessing neck lymph node metastasis of papillary thyroid carcinoma based on metabolomics, proteomics, and imaging omics data, exploring an ideal protocal for the precise diagnosis and treatment of papillary thyroid carcinoma."
Detailed description
This study is a multicenter, observational cohort study aimed at assessing the accuracy and effectiveness of the ThyMPR-CLNM multi-omics model in predicting CLNM in patients diagnosed with stage T1 PTC. The design incorporates the following critical components:
The study enrolled 2000 patients diagnosed with stage T1 PTC from Hangzhou Traditional Chinese Medical Hospital, affiliated with Zhejiang Chinese Medical University, between Dec.2024 and Dec.2026. Fresh frozen tumor tissue, serum samples, and preoperative ultrasound images were collected from participants. These samples were utilized for comprehensive multi-omics analyses, including metabolomic and proteomic profiling, as well as ultrasound radiomic feature extraction. To minimize selection bias and balance covariates, propensity score matching was performed in two rounds, establishing a discovery set and a validation set with matched groups based on the propensity scores calculated through logistic regression. This ensured comparable groups for subsequent analyses. The study involved analyzing the collected samples through advanced techniques such as liquid chromatography-mass spectrometry (LC-MS) for metabolomic and proteomic analyses, and Pyradiomics for extracting radiomics features from ultrasound images. Differentially expressed metabolites, proteins, and radiomic features were identified and integrated for the development of the ThyMPR-CLNM prediction model. The Least Absolute Shrinkage and Selection Operator (LASSO) regression technique was utilized to construct the ThyMPR-CLNM model based on identified features from the multi-omics analyses. The model's performance was subsequently validated using an independent dataset. Statistical evaluations were performed using R software to determine the model's accuracy, sensitivity, specificity, and AUC values. Comparisons with conventional diagnostic methods were conducted to highlight the ThyMPR-CLNM model's advantages.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LNM group and NLNM group | – | Diagnostic Test: Thy_CLNM_multi_omicsThe primary objective of this study is to evaluate the accuracy of the ThyMPR-CLNM model in predicting central lymph node metastasis (CLNM) in patients with stage T1 papillary thyroid carcinoma (PTC). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PTC patients underwent surgery in Hangzhou Traditional Chinese Medical Hospital
Key inclusion criteria (5 listed)
- Pathological confirmation of PTC.
- Patients who underwent primary surgery accompanied by central neck lymph node dissection.
- Tumors measuring less than 2 cm in diameter.
- Postoperative pathological reports including detailed information on the number of lymph nodes dissected and the number of metastatic lymph nodes.
- Availability of comprehensive preoperative thyroid ultrasound images for analysis.
Key exclusion criteria (5 listed)
- Postoperative pathological diagnosis indicating sub-types of PTC.
- Tumor invasion into adjacent anatomic structures such as the sternothyroid muscle, surrounding soft tissues, trachea, esophagus, or laryngeal nerve.
- History of neck trauma, previous tumor surgery, or adjuvant chemoradiotherapy.
- Fewer than three lymph nodes dissected during surgery.
- Concurrent acute inflammatory conditions or other hematologic disorders.
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 |
|---|---|---|
| Thy_CLNM_multi_omicsSurgery | Diagnostic test | LNM group and NLNM group |
Primary outcome
Lymph node metastasis status
Time frame: Record lymph node metastasis status until the end of the surgery, followed by a one-year follow-up until the conclusion of the study.
Patients with thyroid cancer undergo thyroid cancer radical surgery according to the guidelines, with pathological results including the number of lymph node metastases and metastasis status, based on the final pathological diagnosis.
1 secondary outcome
Surgical complications and postoperative recurrence
Time frame: Record surgical complications until the end of the surgery, followed by a one-year follow-up until the conclusion of the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillary Thyroid Carcinoma and Lymph Node Cancer Metastatic, run by Tianhan Zhou.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianhan Zhou (8615556960687, 201911122511374@zcmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph node metastasis status (time frame: Record lymph node metastasis status until the end of the surgery, followed by a one-year follow-up until the conclusion of the study.). 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 10 Dec 2024.