Deep Learning Signature for Predicting Complete Pathological Response to Neoadjuvant Chemoimmunotherapy in Non-small Cell Lung Cancer

June 27, 2023 updated by: Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China

An Integration of a Computed Tomography/Positron Emission Tomography/Whole Slide Image (CT/PET/WSI) Based Deep Learning Signature for Predicting Complete Pathological Response to Neoadjuvant Chemoimmunotherapy in Non-small Cell Lung Cancer: A Multicenter Study

The purpose of this study is to evaluate the performance of a CT/PET/ WSI-based deep learning signature for predicting complete pathological response to neoadjuvant chemoimmunotherapy in non-small cell lung cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guizhou
      • Zunyi, Guizhou, China
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Zhejiang
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo HwaMei Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Resected Stage I-III NSCLC following neoadjuvant chemoimmunotherapy

Description

Inclusion Criteria:

  1. Age ranging from 20-75 years;
  2. Patients who underwent curative surgery after neoadjuvant chemoimmunotherapy for NSCLC;
  3. Obtained written informed consent.

Exclusion Criteria:

  1. Missing image data;
  2. Pathological N3 disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area under the receiver operating characteristic curve
Time Frame: 2023.5.1-2023.10.31
The area under the receiver operating characteristic curve (ROC) of the deep learning model in predicting complete pathological response (CPR). CPR was defined as no residual tumor in both resected primary tumor and lymph nodes. Patients with non-small cell lung cancer receiving neoadjuvant chemoimmunotherapy will achieve either CPR or non-CPR, which can be confirmed by pathological examination after surgical resection. And the model will output the predictive value (CPR/non-CPR) for each patient receiving neoadjuvant chemoimmunotherapy.
2023.5.1-2023.10.31

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 2023.5.1-2023.10.31
The sensitivity of the deep learning model in predicting complete pathological response. CPR was defined as no residual tumor in both resected primary tumor and lymph nodes. Patients with non-small cell lung cancer receiving neoadjuvant chemoimmunotherapy will achieve either CPR or non-CPR, which can be confirmed by pathological examination after surgical resection. And the model will output the predictive value (CPR/non-CPR) for each patient receiving neoadjuvant chemoimmunotherapy.
2023.5.1-2023.10.31

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: 2023.5.1-2023.10.31
The specificity of the deep learning model in predicting complete pathological response. CPR was defined as no residual tumor in both resected primary tumor and lymph nodes. Patients with non-small cell lung cancer receiving neoadjuvant chemoimmunotherapy will achieve either CPR or non-CPR, which can be confirmed by pathological examination after surgical resection. And the model will output the predictive value (CPR/non-CPR) for each patient receiving neoadjuvant chemoimmunotherapy.
2023.5.1-2023.10.31
Positive predictive value
Time Frame: 2023.5.1-2023.10.31
The positive predictive value of the deep learning model in predicting complete pathological response. CPR was defined as no residual tumor in both resected primary tumor and lymph nodes. Patients with non-small cell lung cancer receiving neoadjuvant chemoimmunotherapy will achieve either CPR or non-CPR, which can be confirmed by pathological examination after surgical resection. And the model will output the predictive value (CPR/non-CPR) for each patient receiving neoadjuvant chemoimmunotherapy.
2023.5.1-2023.10.31
Negative predictive value
Time Frame: 2023.5.1-2023.10.31
The negative predictive value of the deep learning model in predicting complete pathological response. CPR was defined as no residual tumor in both resected primary tumor and lymph nodes. Patients with non-small cell lung cancer receiving neoadjuvant chemoimmunotherapy will achieve either CPR or non-CPR, which can be confirmed by pathological examination after surgical resection. And the model will output the predictive value (CPR/non-CPR) for each patient receiving neoadjuvant chemoimmunotherapy.
2023.5.1-2023.10.31
Accuracy
Time Frame: 2023.5.1-2023.10.31
The accuracy of the deep learning model in predicting complete pathological response. CPR was defined as no residual tumor in both resected primary tumor and lymph nodes. Patients with non-small cell lung cancer receiving neoadjuvant chemoimmunotherapy will achieve either CPR or non-CPR, which can be confirmed by pathological examination after surgical resection. And the model will output the predictive value (CPR/non-CPR) for each patient receiving neoadjuvant chemoimmunotherapy.
2023.5.1-2023.10.31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Pulmonary Hospital, Shanghai, China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zunyi Medical College
Ningbo HwaMei Hospital, Zhejiang, China
The First Affiliated Hospital of Nanchang University, Jiangxi, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DLCPR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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