Lymph Nodes With Tumor MetastasisNCT06810349
Predicting Tumor Origin Based on Deep Learning of Lymph Node Puncture Cytology
An observational study of Lymph Nodes With Tumor Metastasis, run by West China Hospital at 1 site in China.
Trial summary
In this study, the investigators aimed to construct a deep learning diagnostic model that uses cytological images to predict primary unknown tumor origins in patients with tumors combined with lymph node metastases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lymph Nodes With Tumor Metastasis
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Lymph node cytology smear imaging data and clinical data in the training cohort were obtained from West China Hospital of Sichuan University (October 1, 2008 to August 31, 2024). Lymph node cytology smear imaging data and clinical data in the validation cohort were obtained from the Department of Pathology of the First Affiliated Hospital of Zhengzhou University, Sichuan Cancer Hospital, and Cancer Hospital of the Chinese Academy of Medical Sciences (January 1, 2020 to August 31, 2024).
Who may be able to join
- From West China Hospital of Sichuan University (October 1, 2008-August 31, 2024) with corresponding clinical data, including age, sex, specimen puncture site, pathologic diagnosis, pathologic type, whether immunocytochemistry was added, clinical diagnosis, lesion site, co-morbidities, history of malignancy, treatment modality, occurrence of postoperative complications, total number of days of hospitalization postoperatively, and survival time;
- From the Department of Pathology of the First Affiliated Hospital of Zhengzhou University, the Sichuan Provincial Cancer Hospital, and the Cancer Hospital of the Chinese Academy of Medical Sciences (January 1, 2020-August 31, 2024) with corresponding clinical data, including age, sex, specimen puncture site, pathologic diagnosis, pathologic type, whether immunocytochemistry was added, clinical diagnosis, lesion site, co-morbidities, history of malignancy, treatment modality, occurrence of postoperative complications, total number of days of hospitalization postoperatively, and survival time.
Who cannot join
- Images lacking any supporting clinical or pathologic evidence to support a primary origin and its corresponding clinical information;
- Blank, poorly focused, and low-quality images containing severe artifacts and their corresponding clinical information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: A Multicenter Study on Predicting Tumor Origin Based on Deep Learning of Lymph Node Puncture Cytology
In this study, the investigators aimed to construct a deep learning diagnostic model that uses cytological images to predict primary unknown tumor origins in patients with tumors combined with lymph node metastases. After the model is constructed, the model will be validated by a large-scale test set to test the model performance. The investigators also propose to compare the performance of the constructed model in diagnosing cytology smears compared to human pathologists.
- Conditions
- Lymph Nodes With Tumor Metastasis
- Keywords
- Primary unknown tumor origin, Deep learning, Cytopathology
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 |
|---|---|---|
| a training cohort and a validation cohort | Training cohort: Lymph node cytology smear imaging data and corresponding clinical data from October 1, 2008-August 31, 2024 in West China Hospital of Sichuan University. Validation cohort: Lymph node cytology smear imaging data and corresponding clinical data from January 1, 2020-August 31, 2024 in the First Affiliated Hospital of Zhengzhou University, Sichuan Provincial Cancer Hospital, and the Cancer Hospital of China Academy of Medical Sciences. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Model performance metrics
Model performance was evaluated by Positive Predictive Value (PPV), Negative Predictive Value (NPV), Accuracy, Sensitivity and Specificity.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start11 Nov 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Nodes With Tumor MetastasisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianyong Lei, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810349
- Sponsor's protocol ID
- 2024 Audit No. (1041)
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The availability of the large amount of cytology image imaging data from the study is limited due to its oversized storage and therefore not publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on Predicting Tumor Origin Based on Deep Learning of Lymph Node Puncture Cytology
- ClinicalTrials.gov ID
- NCT06810349
- Acronym / sponsor ID
- 2024 Audit No. (1041)
- Conditions
- Lymph Nodes With Tumor Metastasis
- Keywords
- Primary unknown tumor origin, Deep learning, Cytopathology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Feb 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.
In this study, the investigators aimed to construct a deep learning diagnostic model that uses cytological images to predict primary unknown tumor origins in patients with tumors combined with lymph node metastases. After the model is constructed, the model will be validated by a large-scale test set to test the model performance. The investigators also propose to compare the performance of the constructed model in diagnosing cytology smears compared to human pathologists.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a training cohort and a validation cohort | – | –Training cohort: Lymph node cytology smear imaging data and corresponding clinical data from October 1, 2008-August 31, 2024 in West China Hospital of Sichuan University. Validation cohort: Lymph node cytology smear imaging data and corresponding clinical data from January 1, 2020-August 31, 2024 in the First Affiliated Hospital of Zhengzhou University, Sichuan Provincial Cancer Hospital, and the Cancer Hospital of China Academy of Medical Sciences. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Lymph node cytology smear imaging data and clinical data in the training cohort were obtained from West China Hospital of Sichuan University (October 1, 2008 to August 31, 2024). Lymph node cytology smear imaging data and clinical data in the validation cohort were obtained from the Department of Pathology of the First Affiliated Hospital of Zhengzhou University, Sichuan Cancer Hospital, and Cancer Hospital of the Chinese Academy of Medical Sciences (January 1, 2020 to August 31, 2024).
Key inclusion criteria (2 listed)
- From West China Hospital of Sichuan University (October 1, 2008-August 31, 2024) with corresponding clinical data, including age, sex, specimen puncture site, pathologic diagnosis, pathologic type, whether immunocytochemistry was added, clinical diagnosis, lesion site, co-morbidities, history of malignancy, treatment modality, occurrence of postoperative complications, total number of days of hospitalization postoperatively, and survival time;
- From the Department of Pathology of the First Affiliated Hospital of Zhengzhou University, the Sichuan Provincial Cancer Hospital, and the Cancer Hospital of the Chinese Academy of Medical Sciences (January 1, 2020-August 31, 2024) with corresponding clinical data, including age, sex, specimen puncture site, pathologic diagnosis, pathologic type, whether immunocytochemistry was added, clinical diagnosis, lesion site, co-morbidities, history of malignancy, treatment modality, occurrence of postoperative complications, total number of days of hospitalization postoperatively, and survival time.
Key exclusion criteria (2 listed)
- Images lacking any supporting clinical or pathologic evidence to support a primary origin and its corresponding clinical information;
- Blank, poorly focused, and low-quality images containing severe artifacts and their corresponding clinical information.
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
Model performance metrics
Time frame: 1 year
Model performance was evaluated by Positive Predictive Value (PPV), Negative Predictive Value (NPV), Accuracy, Sensitivity and Specificity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No. The availability of the large amount of cytology image imaging data from the study is limited due to its oversized storage and therefore not publicly available.
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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.
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 Lymph Nodes With Tumor Metastasis, run by West China Hospital 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 2 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: looking for participants now, as of the sponsor's last update on 5 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianyong Lei (02885423822, guosiyin2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Model performance metrics (time frame: 1 year). 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 2025.