Accurate Diagnosis and Grading of Pediatric Solid Tumors Based on Pathological Large Models

Study Purpose

Pediatric malignancies are the second leading cause of death in the pediatric population, with solid tumors accounting for approximately 60% of all pediatric malignancies. The pathological diagnosis of pediatric solid tumors is highly complex and specialized, because of its diverse tissue morphology, rare tumor subtypes and lack of labeling data, the traditional pathological diagnosis relies on the experience of senior pathologists, but in actual clinical practice, due to the lack of expert resources and inconsistent diagnostic standards, more efficient and accurate auxiliary diagnostic tools are urgently needed. In this study, we aim to construct a multimodal dataset by collecting high-quality pathological images and pathological diagnosis results of pediatric solid tumors (neuroblastoma, medulloblastoma, Wilms tumor, hepatoblastoma, rhabdomyosarcoma, etc.), and introduce medical knowledge enhancement strategies on this basis, and improve the medical reasoning ability and adaptability to fine-grained pathological tasks by injecting domain knowledge (such as molecular characteristics of tumors, pathological grading standards, diagnostic rules, etc.) into the model. Through the model, the representation space of images and texts is unified, and diversified diagnostic tasks of pediatric solid tumors such as tumor region segmentation, cancer detection, and tumor subtype identification are realized, providing intelligent support for the accurate diagnosis and personalized treatment of pediatric solid tumors.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	0 Years - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Neuroblastoma (NB): For newly diagnosed patients with NB aged 0-18 years, the diagnosis criteria are one of the following two items:

(1) the patient's tumor tissue has obtained a positive pathological diagnosis under the light microscope; (2) Bone marrow biopsy or aspiration revealed characteristic neuroblastoma cells, which were small round cells, arranged in a nested or chrysanthemum clump or positive staining for anti-GD2 antibodies, and accompanied by an increase in urinary vanillylmandelic acid (VMA) and an increase in blood neuron-specific enolase (NSE).

2. Wilms tumor (nephroblastoma): patients aged 0-18 years old who have been diagnosed with Wilms tumor by histopathology. 3. Hepatoblastoma (HB): Patients aged 0-18 years who have been diagnosed with hepatoblastoma by histopathology. 4. Medulloblastoma (MB): Patients aged 0-18 years with a confirmed histopathological diagnosis of medulloblastoma. 5. rhabdomyosarcoma (RMS): patients aged 0-18 years old who have been diagnosed with medulloblastoma by histopathology.

Exclusion Criteria:

1. The patient's medical record and treatment follow-up information are incomplete; HE is not stained or faded. 2. Those who have 2 or more types of tumors at the same time; 3. Those who do not meet the enrollment criteria. 4. Tumor subtype with less than 3 WSI images

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06822842
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroblastoma, Medulloblastoma, Wilms Tumor, Hepatoblastoma, Rhabdomyosarcoma

Additional Details

Diagnosis test

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Kun Phd Sun

[email protected]

021-13601846338

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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