CT-based Radiomic Algorithm for Assisting Surgery Decision and Predicting Immunotherapy Response of NSCLC
TOP-RLC
1 other identifier
observational
500
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 25, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedJune 30, 2020
June 1, 2020
2.3 years
June 25, 2020
June 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pathological subtype
Pathological type of pulmonary nodules
5 years
Objective Response Rate (ORR)
Rate of ORR in all subjects for the patients who receiving immunotherapy
5 years
Progression-free survival (PFS)
From enrollment to progression or death (for any reason) in immunotherapy cohort
5 years
Secondary Outcomes (2)
Overall survival (OS)
5 years
Clinical Benefit Rate (CBR)
5 years
Study Arms (4)
Internal cohort
The internal cohort was retrospective enrolled in Guangdong Provincial People's hospital from March 1, 2015 to December 31,2019. Patients with single pulmonary lesion underwent preoperative chest CT scan and histologically confirmed precancerous lesions or early stage lung adenocarcinoma after thoracic surgery was included.
External cohort 1
The same inclusion/exclusion criteria were applied for another independent centers, Sun Yat-sen Memorial Hospital ,Guangdong Province, China, forming an external validation cohort of 73 patients
External cohort 2
The same inclusion/exclusion criteria were applied for another independent centers, Zhoushan Lung Cancer Institution, Zhejiang Province, China, forming second external validation cohort of 30 patients
Immune Cohort
The internal cohort was retrospective enrolled in Guangdong Provincial People's hospital from March 1, 2015 to May 31,2020. Patients with advanced lung cancer underwent preoperative chest CT scan and histologically confirmed NSCLC before receiving immunotherapy was included.
Interventions
Different radiomic and machine learning strategies for radiomic features extraction, sorting features and model constriction
Eligibility Criteria
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.
You may qualify if:
- (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.
You may not qualify if:
- (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.
- (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.
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000, China
Zhoushan Lung Cancer Institution
Zhoushan, Zhejiang, 316000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Haiyu Zhou, PhD
Guangdong Provincial People's Hospital
- PRINCIPAL INVESTIGATOR
Luyu Huang
Guangdong Provincial People's Hospital
- STUDY DIRECTOR
Herui Yao, PhD
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- STUDY DIRECTOR
Yunfang Yu
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- STUDY DIRECTOR
Hanbo Cao, PhD
Zhoushan Lung Cancer Institution
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 25, 2020
First Posted
June 30, 2020
Study Start
August 1, 2019
Primary Completion
December 1, 2021
Study Completion
December 30, 2022
Last Updated
June 30, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share
The datasets used or analysed during the current study are available from the corresponding author on reasonable request.