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

NCT06791174 | Completed

• 1 other identifier: TC-TMECS-SMLNM-1.1
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Keywords

thyroid cancer; collagen; lymph nodes metastasis; predictive model; multiphoton imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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

Patients with thyroid cancer

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead
• Nanfang Hospital, Southern Medical University: collaborator
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin tissue sections of primary tumor site

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Shumin Dong (Princeple Investigator), M.D.

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

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

  The First Affiliated Hospital of Zhengzhou University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 24, 2025
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-01

Locations

CN (1)