CClinicalTrials.gg
RecruitingNCT05925738Updated Jun 29, 2023

Deep Learning Signature for Predicting Aggressive Histological Pattern in Resected Non-small Cell Lung Cancer

An observational study in Non-small Cell Lung Cancer, Spread Through Air Space and Visceral Pleural Invasion, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Recruiting at 3 sites in China. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-29.

Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-small Cell Lung Cancer
  • Spread Through Air Space
  • Visceral Pleural Invasion
  • Lymphovascular Invasion
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 149 studies on the registry; 91 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Resected Stage I-III Non-small Cell Lung Cancer

Inclusion criteria

(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.

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testPET/CT-based Deep Learning Signature

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

06

What researchers measure

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.

    Time frame: 2023.5.1-2023.10.31

Secondary outcomes

  1. Sensitivity

    The sensitivity 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.

    Time frame: 2023.5.1-2023.10.31

Other outcomes

  1. Specificity

    The specificity 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.

    Time frame: 2023.5.1-2023.10.31

  2. Positive predictive value

    The positive predictive value 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.

    Time frame: 2023.5.1-2023.10.31

  3. Negative predictive value

    The negative predictive value 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.

    Time frame: 2023.5.1-2023.10.31

  4. Accuracy

    The accuracy 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.

    Time frame: 2023.5.1-2023.10.31

07

Study locations

3 of 3 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05925738
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Collaborators
Ningbo No.2 Hospital, Zunyi Medical College, The First Affiliated Hospital of Nanchang University
Responsible party
Chang Chen (Professor, Shanghai Pulmonary Hospital, Shanghai, China) — Principal investigator
First posted
Jun 29, 2023
Start date
May 1, 2023
Primary completion
Oct 31, 2023 (estimated)
Completion
Oct 31, 2023 (estimated)
Last update
Jun 29, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion