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Completed

NCT Number: NCT06791174

Tumor Microenvironmental Collagen Signature to Predict Thyroid Cancer Superior Mediastinal Lymph Node Metastasis

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Metastasis status of superior mediastinal lymph nodes

    Time frame: A week after operation generally

    Pathology result of superior mediastinal lymph nodes removed on the day of operation.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Other

Collaborators

  • Nanfang Hospital, Southern Medical University
  • Sir Run Run Shaw Hospital

Registry information

Official study title

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

Acronym: TC-CS-SMLNM

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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