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

NCT ID: NCT06791174

Last Updated: 2025-04-30

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

181 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Thyroid Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Shumin Dong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shumin Dong (Princeple Investigator), M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Detao Yin (Director of Thyroid Surgery Department), M.D.

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Zhengzhou University

Locations

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Countries

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China

Other Identifiers

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TC-TMECS-SMLNM-1.1

Identifier Type: -

Identifier Source: org_study_id

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