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
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
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 100 is below the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 160 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Resected Stage I-III NSCLC following neoadjuvant chemoimmunotherapy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CT/PET/WSI-based Deep Learning Signature for Predicting Complete Pathological Response to Neoadjuvant Chemoimmunotherapy in Non-small Cell Lung Cancer
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
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
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
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
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
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
Plan to share: No
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Started May 2023 (actual). Primary completion is estimated for Oct 2023, 5 months after the start.
Of 355 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 126. This study's planned 5 months is below that.
Counting every sponsor, half of 497 studies reached it within 55 months; a quarter within 35 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
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Carcinoma, Non-Small-Cell Lung →
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