NCT05925738

Brief Summary

The purpose of this study is to evaluate the performance of a PET/ CT-based deep learning signature for predicting aggressive histological pattern in resected non-small cell lung cancer based on a multicenter prospective cohort.

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
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

3 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

May 1, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

May 12, 2023

Last Update Submit

June 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Area under the receiver operating characteristic curve

    The area under the receiver operating characteristic curve (ROC) of the deep learning model in predicting the presence or absence of the aggressive histological pattern. The aggressive histological pattern includes spread through air space (STAS), visceral pleural invasion (VPI), and lymphovascular invasion (LVI). And the model will output all predictive values (presence or absence) of the three kinds of aggressive histological patterns.

    2023.5.1-2023.10.31

Secondary Outcomes (1)

  • Sensitivity

    2023.5.1-2023.10.31

Other Outcomes (4)

  • Specificity

    2023.5.1-2023.10.31

  • Positive predictive value

    2023.5.1-2023.10.31

  • Negative predictive value

    2023.5.1-2023.10.31

  • +1 more other outcomes

Interventions

Deep Learning Signature Based on PET-CT for Predicting the Aggressive Histological Pattern in Resected Non-small Cell Lung Cancer

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Resected Stage I-III Non-small Cell Lung Cancer

You may qualify if:

  • (1) Participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section CT scans; (2) Pathological confirmation of primary NSCLC; (3) Age ranging from 20-75 years; (4) Obtained written informed consent.

You may not qualify if:

  • (1) Multiple lung lesions; (2) Poor quality of PET-CT images; (3) Participants with incomplete clinical information; (4) Participants who have received neoadjuvant therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Ningbo HwaMei Hospital

Ningbo, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

May 12, 2023

First Posted

June 29, 2023

Study Start

May 1, 2023

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations