Clinical trial NCT06791174: Tumor Microenvironmental Collagen Signature to Predict Thyroid Cancer Superior Mediastinal Lymph Node Metastasis
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Keywords: thyroid cancer
collagen
lymph nodes metastasis
predictive model
multiphoton imaging
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Sir Run Run Shaw Hospital
First posted: 2025-01-24
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with thyroid cancer

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metastasis status of superior mediastinal lymph nodes
timeFrame: A week after operation generally
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Shumin Dong (Princeple Investigator), M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Detao Yin (Director of Thyroid Surgery Department), M.D.
role: STUDY_DIRECTOR
References: