Papillary Thyroid Carcinoma; Molecular Heterogeneity; Multi-model Analysis; Artificial Intelligence; Lymph Node Metastases; Disease-free SurvivalNCT06241092
AI-Based Multimodal Multi-tasks Analysis Reveals Tumor Molecular Heterogeneity, Predicts Preoperative Lymph Node Metastasis and Prognosis in Papillary Thyroid Carcinoma
An observational study of Papillary Thyroid Carcinoma; Molecular Heterogeneity; Multi-model Analysis; Artificial Intelligence; Lymph Node Metastases; Disease-free Survival, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This study involved a comprehensive analysis of 256 PTC patients from Sun Yat-sen Memorial Hospital of Sun Yat-sen University (SYSMH) and 499 patients from The Cancer Genome Atlas. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Papillary Thyroid Carcinoma; Molecular Heterogeneity; Multi-model Analysis; Artificial Intelligence; Lymph Node Metastases; Disease-free Survival
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 20 Jan 2025
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥ 18 years of age Diagnosis of Papillary thyroid carcinoma at least one months before trial Willing to return for required follow-up (posttest) visits
Who cannot join
- The patient requires valve or other likely surgery The patient is unable to carry out any physical activity without discomfort The patient had thyroid ache within three months prior to enrollment The patient refuses to give informed consent The patient is a candidate for coronary bypass surgery or something similar
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Herui Yao, PhD, +8613500018020, yaoherui@mail.sysu.edu.cn
Yufang Yu, +8613660238987, yuyf9@mail.sysu.edu.cn
About this study
Official title: AI-Based Multimodal Multi-tasks Analysis Reveals Tumor Molecular Heterogeneity, Predicts Preoperative Lymph Node Metastasis and Prognosis in Papillary Thyroid Carcinoma: A Retrospective Study
This study involved a comprehensive analysis of 256 PTC patients from Sun Yat-sen Memorial Hospital of Sun Yat-sen University (SYSMH) and 499 patients from The Cancer Genome Atlas. DNA-based next-generation sequencing (NGS) and single-cell RNA sequencing (scRNA-seq) were employed to capture genetic alterations and TME heterogeneity. A deep learning multimodal model was developed by incorporating matched histopathology slide images, genomic, transcriptomic, immune cells data to predict LNM and disease-free survival (DFS).
- Medical subject headings
- Thyroid Cancer, Papillary, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| TCGA | Not described | |
| SYSMH | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node metastasis
Lymph node metastasis is frequently influenced by a myriad of factors, and tumor heterogeneity stands out as a significant contributing element.
Measured: 2021.10.1
Secondary outcomes (1)
Disease-free survival
Disease-free survival is defined as the time from randomization to the first occurrence of a relapse, progression, or death from any cause, commonly used in clinical trials of adjuvant therapy after curative surgery or radiation therapy. It is also used as a primary endpoint in studies of neoadjuvant therapy and a useful endpoint for evaluating the efficacy of treatments that aim to prevent cancer recurrence research
Measured: 2021.10.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid Carcinoma; Molecular Heterogeneity; Multi-model Analysis; Artificial Intelligence; Lymph Node Metastases; Disease-free SurvivalStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 256 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunfang Yu, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241092
- Sponsor's protocol ID
- SYSEC-KY-KS-2021-259
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Based Multimodal Multi-tasks Analysis Reveals Tumor Molecular Heterogeneity, Predicts Preoperative Lymph Node Metastasis and Prognosis in Papillary Thyroid Carcinoma: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06241092
- Acronym / sponsor ID
- SYSEC-KY-KS-2021-259
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 5 Feb 2024 (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.
This study involved a comprehensive analysis of 256 PTC patients from Sun Yat-sen Memorial Hospital of Sun Yat-sen University (SYSMH) and 499 patients from The Cancer Genome Atlas. DNA-based next-generation sequencing (NGS) and single-cell RNA sequencing (scRNA-seq) were employed to capture genetic alterations and TME heterogeneity. A deep learning multimodal model was developed by incorporating matched histopathology slide images, genomic, transcriptomic, immune cells data to predict LNM and disease-free survival (DFS).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCGA | – | – |
| SYSMH | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ≥ 18 years of age Diagnosis of Papillary thyroid carcinoma at least one months before trial Willing to return for required follow-up (posttest) visits
Key exclusion criteria (1 listed)
- The patient requires valve or other likely surgery The patient is unable to carry out any physical activity without discomfort The patient had thyroid ache within three months prior to enrollment The patient refuses to give informed consent The patient is a candidate for coronary bypass surgery or something similar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | SYSMH, TCGA |
Primary outcome
Lymph node metastasis
Time frame: 2021.10.1
Lymph node metastasis is frequently influenced by a myriad of factors, and tumor heterogeneity stands out as a significant contributing element.
1 secondary outcome
Disease-free survival
Time frame: 2021.10.1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
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.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, China
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 Papillary Thyroid Carcinoma; Molecular Heterogeneity; Multi-model Analysis; Artificial Intelligence; Lymph Node Metastases; Disease-free Survival, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph node metastasis (time frame: 2021.10.1). 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 5 Feb 2024; AzTrials last refreshed its copy on 31 Oct 2026.