Virtual StainingNCT06486155
Evaluation of Axillary Lymph Node Metastasis Status of Breast Cancer Based on Pathological Images and Virtual Staining
An observational study of Virtual Staining and Lymph Node Metastasis, run by Yunnan Cancer Hospital.
Trial summary
The goal of this observational study is to develop an artificial intelligence model to transform unstained lymph node tissue slice images directly into stained images. The main questions it aims to answer are: Can the virtual staining model generate hematoxylin and eosin (H\&E) and immunohistochemistry (IHC) images… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Virtual Staining, Lymph Node Metastasis, Breast Cancer
- How many people
- 2,200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 2025
- How long will I take part?
- 5 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Part 1: The investigators plan to collect 1000 patients with breast cancer. Part 2: The investigators plan to collect 100 patients with each of the following cancers: thyroid, lung, esophagus, stomach, colorectal, prostate, bladder, and cervix. The total number of patients will be 800. Part 3: The investigators plan to prospectively collect 400 patients with breast cancer.
Who may be able to join
- Part 1:
- Female patients aged 18-75 with breast cancer; Undergoing surgical excision of breast cancer and sentinel lymph node biopsy/axillary lymph node dissection; Lymph nodes with clear postoperative paraffin pathological results.
- Part 2:
- Patients aged 18-75 with one of the following cancers: thyroid, lung, esophagus, stomach, colorectal, prostate, bladder, or cervix; Undergoing surgical resection of lymph nodes; Lymph nodes with clear postoperative paraffin pathological results.
- Part 3:
- Female patients aged 18-75 with breast cancer; Undergoing surgical excision of breast cancer and sentinel lymph node biopsy; Sentinel lymph nodes with clear postoperative paraffin pathological results.
Who cannot join
- Part 1 / Part 2:
- Lymph node diagnosis is missing; Absence of lymph node component in the slice.
- Part 3:
- Sentinel lymph node diagnosis is missing; Absence of lymph node component in the frozen slice.
About this study
The goal of this observational study is to develop an artificial intelligence model to transform unstained lymph node tissue slice images directly into stained images. The main questions it aims to answer are:
Can the virtual staining model generate hematoxylin and eosin (H\&E) and immunohistochemistry (IHC) images suitable for clinical diagnosis from unstained paraffin-embedded lymph node slice images, including those from breast axillary lymph nodes and other tumor lymph nodes?
Read more
Can the virtual staining model generate H\&E and IHC images suitable for clinical diagnosis from unstained frozen sentinel lymph node slice images from breast cancer patients?
Researchers will retrospectively collect paraffin-embedded lymph node slices from tumor patients and prospectively collect frozen sentinel lymph node slices from breast cancer patients.
- Medical subject headings
- Lymphatic Metastasis, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node metastasis status
Lymph node metastasis status: metastasis or non-metastasis
Measured: 2024-2025
Accuracy, Sensitivity, Specificity，Area under the curve，
The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images
Measured: 2024-2025
Positive predictive value，Negative predictive value
The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images
Measured: 2024-2025
Secondary outcomes (3)
Peak Signal-to-Noise Ratio(PSNR)
Scores of the similarity between virtual and real staining of lymph nodes, with values ranging from 0 to infinity, the higher scores mean the better outcomes
Measured: 2024-2025
Multi-Scale Structural Similarity (MS-SSIM)
Scores of the similarity between virtual and real staining of lymph nodes, with values ranging from 0 to 1, the higher scores mean the better outcomes
Measured: 2024-2025
Pearson correlation coefficient
Scores of the similarity between virtual and real staining of lymph nodes, with values ranging from 0 to 1, the higher scores mean the better outcomes
Measured: 2024-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionJun 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 Virtual StainingStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Cancer Hospital of Shantou University Medical College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486155
- Sponsor's protocol ID
- KYLX2024-129
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 13 Aug 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Axillary Lymph Node Metastasis Status of Breast Cancer Based on Pathological Images and Virtual Staining
- ClinicalTrials.gov ID
- NCT06486155
- Acronym / sponsor ID
- KYLX2024-129
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Collaborators
- Affiliated Cancer Hospital of Shantou University Medical College
- Study start
- Aug 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Jul 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.
The goal of this observational study is to develop an artificial intelligence model to transform unstained lymph node tissue slice images directly into stained images. The main questions it aims to answer are:
Can the virtual staining model generate hematoxylin and eosin (H\&E) and immunohistochemistry (IHC) images suitable for clinical diagnosis from unstained paraffin-embedded lymph node slice images, including those from breast axillary lymph nodes and other tumor lymph nodes?
Can the virtual staining model generate H\&E and IHC images suitable for clinical diagnosis from unstained frozen sentinel lymph node slice images from breast cancer patients?
Researchers will retrospectively collect paraffin-embedded lymph node slices from tumor patients and prospectively collect frozen sentinel lymph node slices from breast cancer patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Part 1: The investigators plan to collect 1000 patients with breast cancer. Part 2: The investigators plan to collect 100 patients with each of the following cancers: thyroid, lung, esophagus, stomach, colorectal, prostate, bladder, and cervix. The total number of patients will be 800. Part 3: The investigators plan to prospectively collect 400 patients with breast cancer.
Key inclusion criteria (6 listed)
- Female patients aged 18-75 with breast cancer; Undergoing surgical excision of breast cancer and sentinel lymph node biopsy/axillary lymph node dissection; Lymph nodes with clear postoperative paraffin pathological results.
- Patients aged 18-75 with one of the following cancers: thyroid, lung, esophagus, stomach, colorectal, prostate, bladder, or cervix; Undergoing surgical resection of lymph nodes; Lymph nodes with clear postoperative paraffin pathological results.
- Female patients aged 18-75 with breast cancer; Undergoing surgical excision of breast cancer and sentinel lymph node biopsy; Sentinel lymph nodes with clear postoperative paraffin pathological results.
Key exclusion criteria (4 listed)
- Lymph node diagnosis is missing; Absence of lymph node component in the slice.
- Sentinel lymph node diagnosis is missing; Absence of lymph node component in the frozen slice.
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
Lymph node metastasis status
Time frame: 2024-2025
Lymph node metastasis status: metastasis or non-metastasis
Accuracy, Sensitivity, Specificity，Area under the curve，
Time frame: 2024-2025
The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images
Positive predictive value，Negative predictive value
Time frame: 2024-2025
The performance of pathologists diagnosing the lymph node metastasis status by virtual and real staining whole slide images
3 secondary outcomes
Peak Signal-to-Noise Ratio(PSNR)
Time frame: 2024-2025
Multi-Scale Structural Similarity (MS-SSIM)
Time frame: 2024-2025
Pearson correlation coefficient
Time frame: 2024-2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Virtual Staining and Lymph Node Metastasis, run by Yunnan Cancer Hospital.
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 6 inclusion and 4 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 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Lymph node metastasis status (time frame: 2024-2025). The study lists 3 primary outcomes in all. 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 13 Aug 2024.