Multiomics Study of Biological Behavior of Lymph Node Metastasis in Papillary Thyroid Carcinoma
NCT ID: NCT06725628
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
2000 participants
OBSERVATIONAL
2024-12-01
2024-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
Thy_CLNM_multi_omics
Surgery
Interventions
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Thy_CLNM_multi_omics
Surgery
Eligibility Criteria
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Inclusion Criteria
2. Patients who underwent primary surgery accompanied by central neck lymph node dissection.
3. Tumors measuring less than 2 cm in diameter.
4. Postoperative pathological reports including detailed information on the number of lymph nodes dissected and the number of metastatic lymph nodes.
5. Availability of comprehensive preoperative thyroid ultrasound images for analysis.
Exclusion Criteria
2. Tumor invasion into adjacent anatomic structures such as the sternothyroid muscle, surrounding soft tissues, trachea, esophagus, or laryngeal nerve.
3. History of neck trauma, previous tumor surgery, or adjuvant chemoradiotherapy.
4. Fewer than three lymph nodes dissected during surgery.
5. Concurrent acute inflammatory conditions or other hematologic disorders.
18 Years
80 Years
ALL
No
Sponsors
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Tianhan Zhou
OTHER_GOV
Responsible Party
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Tianhan Zhou
Clinical Professor
Central Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2022ZA119
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2022KY153-CX1
Identifier Type: -
Identifier Source: org_study_id