Thyroid CancerTC-CS-SMLNMNCT06791174
Tumor Microenvironmental Collagen Signature to Predict Thyroid Cancer Superior Mediastinal Lymph Node Metastasis
An observational study of Thyroid Cancer, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thyroid Cancer
- How many people
- 181 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with thyroid cancer
Who may be able to join
- Pathologically diagnosed as thyroid cancer
- Radical surgery of tumor and simultaneous resection of superior mediastinal lymph nodes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
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
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.
Read the 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.
- Conditions
- Thyroid Cancer
- Keywords
- thyroid cancer, collagen, lymph nodes metastasis, predictive model, multiphoton imaging
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Metastasis status of superior mediastinal lymph nodes
Pathology result of superior mediastinal lymph nodes removed on the day of operation.
Measured: A week after operation generally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shumin Dong, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Shumin Dong (Princeple Investigator), M.D., Principal investigator, The First Affiliated Hospital of Zhengzhou UniversityDetao Yin (Director of Thyroid Surgery Department), M.D., Study director, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791174
- Sponsor's protocol ID
- TC-TMECS-SMLNM-1.1
- Acronym
- TC-CS-SMLNM
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06791174
- Acronym / sponsor ID
- TC-CS-SMLNM / TC-TMECS-SMLNM-1.1
- Conditions
- Thyroid Cancer
- Keywords
- thyroid cancer, collagen, lymph nodes metastasis, predictive model, multiphoton imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Sir Run Run Shaw Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thyroid cancer
Key inclusion criteria (2 listed)
- Pathologically diagnosed as thyroid cancer
- Radical surgery of tumor and simultaneous resection of superior mediastinal lymph nodes
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shumin Dong (Princeple Investigator), M.D. principal investigator
The First Affiliated Hospital of Zhengzhou University
Detao Yin (Director of Thyroid Surgery Department), M.D. study director
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metastasis status of superior mediastinal lymph nodes (time frame: A week after operation generally). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.