NCT05300113

Brief Summary

CNS tumor requires biopsy for pathological diagnosis, which is known as the "golden standard". We would like to achieve automated classification of brain tumors based on deep learning in digital histopathology images and molecular pathology results. We expect to develop an assistant system (including software and hardware), to help pathologists during their diagnosis for CNS tumor.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

March 20, 2022

Last Update Submit

March 20, 2022

Conditions

Keywords

CNS Tumor, Neuropathology, Deep Learning

Outcome Measures

Primary Outcomes (3)

  • Automated histopathological diagnosis outcome (software development)

    After supervised training, the software of the histopathological diagnosis of CNS tumor achieve at least 70% accuracy

    Nov,2018 - Nov,2019

  • Positioning platform for microscope (hardware development)

    Hardware investigation for pathology section image collection, to automatically scan the section images.

    Nov,2018 - Nov,2019

  • Combine automated molecular pathological diagnosis

    Molecular information being added to the histopathological diagnosis regarding to WHO 2016 CNS Tumor guide. Combine histopathology and molecular to give final diagnosis

    Nov,2019 - Jun,2020

Secondary Outcomes (1)

  • Unsupervised training with more cases to improve the system

    Nov,2019 - Nov,2022

Study Arms (1)

CNS Tumor

All patients age from 18-75 years with CNS tumors are included and count as one group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients enrolled from neurosurgery department of Huashan hospital.

You may qualify if:

  • The participants diagnosed with brain cancer by diagnosis of WHO 2016 classification of CNS tumors.

You may not qualify if:

  • Voluntarily quit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hushan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (8)

  • Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, Ohgaki H, Wiestler OD, Kleihues P, Ellison DW. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016 Jun;131(6):803-20. doi: 10.1007/s00401-016-1545-1. Epub 2016 May 9.

    PMID: 27157931BACKGROUND
  • Wen PY, Huse JT. 2016 World Health Organization Classification of Central Nervous System Tumors. Continuum (Minneap Minn). 2017 Dec;23(6, Neuro-oncology):1531-1547. doi: 10.1212/CON.0000000000000536.

    PMID: 29200109BACKGROUND
  • Schmidhuber J. Deep learning in neural networks: an overview. Neural Netw. 2015 Jan;61:85-117. doi: 10.1016/j.neunet.2014.09.003. Epub 2014 Oct 13.

    PMID: 25462637BACKGROUND
  • Yu KH, Zhang C, Berry GJ, Altman RB, Re C, Rubin DL, Snyder M. Predicting non-small cell lung cancer prognosis by fully automated microscopic pathology image features. Nat Commun. 2016 Aug 16;7:12474. doi: 10.1038/ncomms12474.

    PMID: 27527408BACKGROUND
  • Ehteshami Bejnordi B, Veta M, Johannes van Diest P, van Ginneken B, Karssemeijer N, Litjens G, van der Laak JAWM; the CAMELYON16 Consortium; Hermsen M, Manson QF, Balkenhol M, Geessink O, Stathonikos N, van Dijk MC, Bult P, Beca F, Beck AH, Wang D, Khosla A, Gargeya R, Irshad H, Zhong A, Dou Q, Li Q, Chen H, Lin HJ, Heng PA, Hass C, Bruni E, Wong Q, Halici U, Oner MU, Cetin-Atalay R, Berseth M, Khvatkov V, Vylegzhanin A, Kraus O, Shaban M, Rajpoot N, Awan R, Sirinukunwattana K, Qaiser T, Tsang YW, Tellez D, Annuscheit J, Hufnagl P, Valkonen M, Kartasalo K, Latonen L, Ruusuvuori P, Liimatainen K, Albarqouni S, Mungal B, George A, Demirci S, Navab N, Watanabe S, Seno S, Takenaka Y, Matsuda H, Ahmady Phoulady H, Kovalev V, Kalinovsky A, Liauchuk V, Bueno G, Fernandez-Carrobles MM, Serrano I, Deniz O, Racoceanu D, Venancio R. Diagnostic Assessment of Deep Learning Algorithms for Detection of Lymph Node Metastases in Women With Breast Cancer. JAMA. 2017 Dec 12;318(22):2199-2210. doi: 10.1001/jama.2017.14585.

    PMID: 29234806BACKGROUND
  • Esteva A, Kuprel B, Novoa RA, Ko J, Swetter SM, Blau HM, Thrun S. Dermatologist-level classification of skin cancer with deep neural networks. Nature. 2017 Feb 2;542(7639):115-118. doi: 10.1038/nature21056. Epub 2017 Jan 25.

    PMID: 28117445BACKGROUND
  • Gulshan V, Peng L, Coram M, Stumpe MC, Wu D, Narayanaswamy A, Venugopalan S, Widner K, Madams T, Cuadros J, Kim R, Raman R, Nelson PC, Mega JL, Webster DR. Development and Validation of a Deep Learning Algorithm for Detection of Diabetic Retinopathy in Retinal Fundus Photographs. JAMA. 2016 Dec 13;316(22):2402-2410. doi: 10.1001/jama.2016.17216.

    PMID: 27898976BACKGROUND
  • Litjens G, Kooi T, Bejnordi BE, Setio AAA, Ciompi F, Ghafoorian M, van der Laak JAWM, van Ginneken B, Sanchez CI. A survey on deep learning in medical image analysis. Med Image Anal. 2017 Dec;42:60-88. doi: 10.1016/j.media.2017.07.005. Epub 2017 Jul 26.

    PMID: 28778026BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Pathological Section

MeSH Terms

Conditions

Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Study Officials

  • Jinsong Wu, Ph.D. & M.D

    Huashan Hospital

    STUDY CHAIR

Central Study Contacts

Jinsong Wu, Ph.D. & M.D.

CONTACT

Lei Jin, B.S.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2022

First Posted

March 29, 2022

Study Start

May 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

March 29, 2022

Record last verified: 2022-03

Locations