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RecruitingNCT05925751Updated Jun 29, 2023

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

An observational study in Non-small Cell Lung Cancer, Neoadjuvant Chemoimmunotherapy and Complete Pathological Response, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Recruiting at 3 sites in China. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-29.

Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Non-small Cell Lung Cancer
  • Neoadjuvant Chemoimmunotherapy
  • Complete Pathological Response
03

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Resected Stage I-III NSCLC following neoadjuvant chemoimmunotherapy

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

Exclusion Criteria:

  1. Missing image data;
  2. Pathological N3 disease.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testCT/PET/WSI-based Deep Learning Signature

    CT/PET/WSI-based Deep Learning Signature for Predicting Complete Pathological Response to Neoadjuvant Chemoimmunotherapy in Non-small Cell Lung Cancer

05

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 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.

    Time frame: 2023.5.1-2023.10.31

Secondary outcomes

  1. Sensitivity

    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.

    Time frame: 2023.5.1-2023.10.31

Other outcomes

  1. Specificity

    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.

    Time frame: 2023.5.1-2023.10.31

  2. Positive predictive value

    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.

    Time frame: 2023.5.1-2023.10.31

  3. Negative predictive value

    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.

    Time frame: 2023.5.1-2023.10.31

  4. Accuracy

    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.

    Time frame: 2023.5.1-2023.10.31

06

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
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05925751
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 ↗

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