NCT05221814

Brief Summary

This study aimed to develop a deep-learning model to automatically classify pulmonary nodules based on white-light images and to evaluate the model performance. Besides, suitable operation could be chosen with the help of this model, which could shorten the time of surgery.

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
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

June 1, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

January 5, 2022

Last Update Submit

January 23, 2022

Conditions

Keywords

lung cancerpathologic predictiondeep learning

Outcome Measures

Primary Outcomes (2)

  • 1. Pathological subtype

    According to WHO classification of pulmonary tumors in 2020, this study classify pulmonary tumors into adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA) and invasive adenocarcinoma (IAC). We would collect the reports of pathological type of pulmonary nodules after surgery.

    through study completion, an average of 2 year

  • Area Under the Curve (AUC)

    The area under the ROC curve based the predicton efficency of model

    through study completion, an average of 2 year

Interventions

Whether apply gross pathologic photo based deep learning model to predict pathologic subtype

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in Guangdong Provincial People's hospital from June 30, 2020 to September 15, 2021.

You may qualify if:

  • Male or female,18 years and older.
  • Patients haven't undergone any therapy.
  • The pulmonary nodules were confirmed AIS, MIA or IAC.
  • The sizes of pulmonary nodules were less than 3cm.
  • The images were jpg format.

You may not qualify if:

  • Suffering from other tumor disease before or at the same time.
  • Images with poor quality or low resolution that precluded proper classification.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guagndong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Haiyu Zhou

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice-president

Study Record Dates

First Submitted

January 5, 2022

First Posted

February 3, 2022

Study Start

June 1, 2020

Primary Completion

June 1, 2022

Study Completion

January 1, 2023

Last Updated

February 3, 2022

Record last verified: 2022-01

Locations