Tumor Microenvironmental Collagen Signature to Predict Thyroid Cancer Superior Mediastinal Lymph Node Metastasis (TC-CS-SMLNM)

Development and Validation of a Tumor Microenvironmental Collagen Signature Based on Multiphoton Imaging to Predict Superior Mediastinal Lymph Node Metastasis of Patients With Thyroid Cancer

About 7-13% thyroid cancer patients have superior mediastinal lymph node metastasis, but its clinical identification is insufficient. Effective and individualized identification strategy need to be studied. Multiphoton imaging can accurately detect extracellular matrix collagen fibers by femtosecond laser. Quantitative features such as morphology and texture features extracted from the multiphoton images, can be used to predict lymph node metastasis of gastrointestinal cancer. Therefore, the investigators speculate that the characteristics of tumor microenvironment (TME) collagen based on multiphoton imaging may be used to predict superior mediastinal lymph node metastasis in thyroid cancer. The aim of this study is to investigate whether the TME collagen signature could predict superior mediastinal lymph nodes metastasis in thyroid cancer. The exposure of this observational cohort study is high TME collagen signature. The main measurement was the area under the receiver operating characteristic (AUROC) curves of collagen signature for predicting superior mediastinal lymph node metastasis.

Study Overview

• Status: Completed
• Conditions: Thyroid Cancer

Detailed Description

Retrospective cohorts were enrolled from the Sir Run Run Shaw Hospital of Zhejiang University School of Medicine, The First Affiliated Hospital of Zhengzhou University and Nanfang Hospital from January 2020 to December 2023. Perspective cohort was obtained from all the three centers from January 2024 to July 2024.

• Study Type: Observational
• Enrollment (Actual): 181

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with thyroid cancer

Description

Inclusion Criteria:

• Pathologically diagnosed as thyroid cancer
• Radical surgery of tumor and simultaneous resection of superior mediastinal lymph nodes

Exclusion Criteria:

• Reoperation
• Under the age of 18
• Combined with thoracopathy, lymphoma or other diseases that may cause mediastinal lymph node enlargement
• The superior mediastinal lymph nodes metastasis status was not separately reported
• Insufficient pathology section quality
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
High TME Collagen Signature Group; The group with high tumor microenvironmental(TME) collagen signature. The TME collagen signature was developed in the training cohort and validated in external validation cohort and prospective cohort. The cutoff point of collagen signature was set according to the metastasis status of superior mediastinal lymph nodes.
Low TME Collagen Signature Group; The group with low tumor microenvironmental(TME) collagen signature. The TME collagen signature was developed in the training cohort and validated in external validation cohort and prospective cohort. The cutoff point of collagen signature was set according to the metastasis status of superior mediastinal lymph nodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metastasis status of superior mediastinal lymph nodes	Pathology result of superior mediastinal lymph nodes removed on the day of operation.	A week after operation generally

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborators: Sir Run Run Shaw Hospital; Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Shumin Dong (Princeple Investigator), M.D., The First Affiliated Hospital of Zhengzhou University; Study Director: Detao Yin (Director of Thyroid Surgery Department), M.D., The First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 18, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: collagen; thyroid cancer; predictive model; lymph nodes metastasis; multiphoton imaging
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplastic Processes; Thyroid Diseases; Neoplasm Metastasis; Thyroid Neoplasms; Lymphatic Metastasis
• Other Study ID Numbers: TC-TMECS-SMLNM-1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No