Multiomics Study of Biological Behavior of Lymph Node Metastasis in Papillary Thyroid Carcinoma

NCT06725628 | Not Yet Recruiting

• 2 other identifiers: 2022KY153-CX12022ZA119
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief 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."

Conditions

Papillary Thyroid Carcinoma; Lymph Node Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Record surgical complications until the end of the surgery, followed by a one-year follow-up until the conclusion of the study.

Study Arms (1)

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).

Diagnostic Test: Thy_CLNM_multi_omics

Interventions

Thy_CLNM_multi_omics DIAGNOSTIC_TEST

Surgery

LNM group and NLNM group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PTC patients underwent surgery in Hangzhou Traditional Chinese Medical Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianhan Zhou: lead

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Central Study Contacts

Tianhan Zhou

CONTACT

8615556960687; 201911122511374@zcmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 10, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share