Therapeutic Resistance Prediction of Tyrosine Kinase Inhibitors

January 17, 2017 updated by: Chongwei Chi, Ph.D, Chinese Academy of Sciences

Association of Computed Tomography Phenotypic Signature With Progression-free Survival in Stage IV EGFR-mutant Non-small Cell Lung Cancer Undergoing Tyrosine Kinase Inhibitors

The investigators propose a non-invasive prognostic tool for TKIs resistance in patients with stage IV EGFR-mutant non-small cell lung cancer (NSCLC) by computed tomography phenotypic features, which can be conveniently translated to facilitate the pre-therapy individualized management of EGFR TKIs in this disease.

Study Overview

Status

Unknown

Conditions

Detailed Description

The investigators develop a multi-CT-phenotypic-feature-based classifier to predict TKI benefit and therapeutic resistance for stage IV EGFR-mutant non-small cell lung cancer (NSCLC). The investigators also compared its prognostic and predictive efficacy with single features and clinicopathological risk factors. An individualized nomogram integrated the classifier and three clinicopathological risk factors was built for clinical use. The prognostic accuracy of the proposed model was evaluated in two independent validation sets.

Nearly 500 patients will be enrolled in this clinical trial. Eligible patients were diagnosed with NSCLC, and stage IV according to the TNM system classification of the American Joint Committee on Cancer, presence of activating EGFR mutations, age 20 years or older, and no history of systemic anticancer therapy for advanced disease. Patients who underwent first-line or second-line EGFR TKIs were eligible for inclusion. All patients had to be capable of undergoing contrast-enhanced CT, and pretreatment CT was strictly controlled in two weeks before the EGFR TKIs starts. Patients who underwent resection for local advanced or metastatic disease were withdrawn from the study.

Therapeutic resistance was measured by PFS, as the time from the initiation of EGFR TKIs therapy to the date of confirmed disease progression or death. PFS was censored at the date of death from other causes, or the date of the last follow-up visit for progression-free patients.

The investigators will use extracted 1000 phenotypic features on the region of interest manually segmented by radiologists. The Lasso Cox regression model and Nomogram will be used to build a prognosis model for the therapeutic resistance prediction of EGFR TKIs for stage IV EGFR-mutant NSCLC. The Harrell's concordance index(C-index) of the proposed nomogram will be used to quantify the discrimination performance.

Study Type

Observational

Enrollment (Anticipated)

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100190
        • Key Laboratory of Molecular Imaging, Chinese Academy of Sciences

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

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Currently, a cohort of 300 patients has already been collected from the collaborating hospitals. Next, the 3 hospitals will collect at least 200 patients within 1 years.

Description

Inclusion Criteria:

  • Eligible patients were diagnosed with NSCLC, and stage IV according to the TNM system classification of the American Joint Committee on Cancer.
  • Presence of activating EGFR mutations.
  • Age 20 years or older, and no history of systemic anticancer therapy for advanced disease.
  • Patients who underwent first-line or second-line EGFR TKIs were eligible for inclusion.
  • All patients had to be capable of undergoing contrast-enhanced CT, and pretreatment CT was strictly controlled in two weeks before the EGFR TKIs starts.

Exclusion Criteria:

  • Based on the criteria above, patients who underwent resection for local advanced or metastatic disease were withdrawn from the study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Chinese Academy of Sciences

Collaborators

Guangdong Academy of Medical Sciences
West China Hospital
Shanghai Pulmonary Hospital, Shanghai, China

Investigators

  • Principal Investigator: Jiangdian Song, Ph.D., CAS Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 1, 2016

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160728TRPN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Non-small Cell Lung Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe