CT-based Radiomic Algorithm for Assisting Surgery Decision and Predicting Immunotherapy Response of NSCLC (TOP-RLC)

June 29, 2020 updated by: Herui Yao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510000
    • Zhejiang
      • Zhoushan, Zhejiang, China, 316000
        • Recruiting
        • Zhoushan Lung Cancer Institution
        • Contact:
          • Hanbo Cao, PhD
          • Phone Number: 13567690608

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Radiomic Algorithm
Different radiomic and machine learning strategies for radiomic features extraction, sorting features and model constriction
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
Other: Radiomic Algorithm
Different radiomic and machine learning strategies for radiomic features extraction, sorting features and model constriction
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
Other: Radiomic Algorithm
Different radiomic and machine learning strategies for radiomic features extraction, sorting features and model constriction
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.
Other: Radiomic Algorithm
Different radiomic and machine learning strategies for radiomic features extraction, sorting features and model constriction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathological subtype
Time Frame: 5 years
Pathological type of pulmonary nodules
5 years
Objective Response Rate (ORR)
Time Frame: 5 years
Rate of ORR in all subjects for the patients who receiving immunotherapy
5 years
Progression-free survival (PFS)
Time Frame: 5 years
From enrollment to progression or death (for any reason) in immunotherapy cohort
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 5 years
From enrollment to death (for any reason) in immunotherapy cohort
5 years
Clinical Benefit Rate (CBR)
Time Frame: 5 years
Rate of CBR greater than or equal to 24 weeks in all subjects
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guangdong Provincial People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYSEC-KY-KS-2019-107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used or analysed during the current study are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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