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

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05925751
Collaborator
Ningbo HwaMei Hospital, Zhejiang, China (Other), Zunyi Medical College (Other), The First Affiliated Hospital of Nanchang University, Jiangxi, China (Other)
100
3
6
33.3
5.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CT/PET/WSI-based Deep Learning Signature

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Area under the receiver operating characteristic curve [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.

Secondary Outcome Measures

  1. Sensitivity [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.

Other Outcome Measures

  1. Specificity [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.

  2. Positive predictive value [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.

  3. Negative predictive value [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.

  4. Accuracy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated Hospital of Zunyi Medical University Zunyi Guizhou China
2 The First Affiliated Hospital of Nanchang University Nanchang Jiangxi China
3 Ningbo HwaMei Hospital Ningbo Zhejiang China

Sponsors and Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China
  • Ningbo HwaMei Hospital, Zhejiang, China
  • Zunyi Medical College
  • The First Affiliated Hospital of Nanchang University, Jiangxi, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Chen, Professor, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier:
NCT05925751
Other Study ID Numbers:
  • DLCPR
First Posted:
Jun 29, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2023