Clinical trial NCT04452058: CT-based Radiomic Algorithm for Assisting Surgery Decision and Predicting Immunotherapy Response of NSCLC
Official title: CT-based Radiomic Algorithm for Assisting Surgery Decision and Predicting Immunotherapy Response of NSCLC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Predictive Cancer Model
Lung Cancer
Preinvasive Adenocarcinoma
Keywords: Radiomics
Early stage
Pulmonary nodule
Pericancerous tissue
Immunotherapy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
First posted: 2020-06-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in Guangdong Provincial People's hospital from March 1, 2015 to May 31,2022.

Patients from Sun Yat-sen Memorial Hospital ,Guangdong Province, China ; Zhoushan Lung Cancer Institution,Zhejiang Province,China during 2019.01-2022.3

All Patients should be histologically confirmed NSCLC and those have preoperative chest CT scan.

Brief summary: The purpose of this study was to investigate whether the combined radiomic model based on radiomic features extracted from focus and perifocal area (5mm) can effectively improve prediction performance of distinguishing precancerous lesions from early-stage lung adenocarcinoma, which could assist clinical decision making for surgery indication. Besides, response and long term clinical benefit of immunotherapy of advanced NSCLC lung cancer patients could also be predicted by this strategy.

Detailed description: Early detection and diagnosis of pulmonary nodules is clinically significant regarding optimal treatment selection and avoidance of unnecessary surgical procedures. Deferential pathology results causes widely different prognosis after standard surgery among pulmonary precancerous lesion, atypical adenomatous hyperplasia (AAH) as well as adenocarcinoma in situ (AIS), and early stage invasive adenocarcinoma (IAC). The micro-invasion of pulmonary perifocal interstitium is difficult to identify from AIS unless pathology immunohistochemical study was implemented after operation，which may causes prolonged procedure time and inappropriate surgical decision-making. Key feature-derived variables screened from CT scans via statistics and machine learning algorithms, could form a radiomics signature for disease diagnosis, tumor staging, therapy response adn patient prognosis. The purpose of this study was to investigate whether the combined radiomic signature based on the focal and perifocal（5mm）radiomic features can effectively improve predictive performance of distinguishing precancerous lesions from early stage lung adenocarcinoma. Besides, immunotherapy response is various among patients and no more than 20% of patients could benefit from it. None reliable biomarker has been found yet expect Programmed death-ligand 1 (PD-L1) expression, the only approved biomarker for immunotherapy. However recent reports suggested that patients could benefit from immunotherapy regardless of PD-L1 positive or negative. On the contrast, radiomics has show it advantages of non-invasiveness, easy-acquired and no limitation of sampling. Therefore, we applied this strategy in prediction for the immunotherapy response of advanced NSCLC lung cancer patients receiving immune checkpoint inhibitors (ICIs), which would prevent some non-benefit patient from the adverse effect of ICIs.

Eligibility criteria: Inclusion Criteria:

* (a) that were pathologically confirmed as precancerous lesions or Stage I lung adenocarcinoma （≤3cm）
* (b) standard Chest CT scans with or without contrast enhancement performed \<3 months before surgery；
* (c) availability of clinical characteristics.

Exclusion Criteria:

* (a) preoperative therapy (neoadjuvant chemotherapy or radiotherapy) performed,
* (b) suffering from other tumor disease before or at the same time.
* (c) Contain other pathological components such as squamous cell lung carcinoma (SCC) or small cell lung carcinoma (SCLC) or
* (d) poor image quality.

Inclusion Criteria of immunotherapy cohort:

* (a) that were diagnosed as advanced NSCLC
* (b) Both standard Chest CT scans with contrast enhancement performed \<3 months before and after first dose of immunotherapy are available；
* (c) availability of clinical characteristics.

Exclusion Criteria of immunotherapy cohort:

* (a) Ever receiving pulmonary operation on the same side of the lesion.
* (b) suffering from other tumor disease before or at the same time.
* (c) Contain other pathological components( SCLC or lymphoma) or
* (d) poor image quality.
* (e) incomplete clinical data.

Primary outcomes:
measure: Pathological subtype
timeFrame: 5 years
measure: Objective Response Rate (ORR)
timeFrame: 5 years
measure: Progression-free survival (PFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
measure: Clinical Benefit Rate (CBR)
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
city: Zhoushan
country: China
facility: Zhoushan Lung Cancer Institution
state: Zhejiang
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Haiyu Zhou, PhD
role: STUDY_CHAIR
affiliation: Guangdong Provincial People's Hospital
name: Luyu Huang
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Herui Yao, PhD
role: STUDY_DIRECTOR
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yunfang Yu
role: STUDY_DIRECTOR
affiliation: Zhoushan Lung Cancer Institution
name: Hanbo Cao, PhD
role: STUDY_DIRECTOR
References: