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Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following Resection (EVOLUTION)

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ClinicalTrials.gov Identifier: NCT04238130
Recruitment Status : Unknown
Verified January 2020 by Si-Yu Wang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : January 23, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Hangzhou Repugene Technology Co., Ltd.
Information provided by (Responsible Party):
Si-Yu Wang, Sun Yat-sen University

Study Description
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Brief Summary:
Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer Diagnostic Test: Perioperative ctDNA Dynamic Monitoring

Detailed Description:
Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. Advances in DNA sequencing technologies and our understanding of the molecular biology of tumours have resulted in increased interest in exploiting ctDNA as a tool to facilitate earlier detection of cancer and thereby improve therapeutic outcomes by enabling early intervention. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators aim to evaluate whether driver gene mutations detected by PEAC can replace tissue testing results in patients with stage I to Ⅲ NSCLC. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation Perioperative Dynamic Changes in ctDNA From Patients of Non-Small-Cell Lung Cancer Following Resection for Relapse Prediction
Actual Study Start Date : December 18, 2019
Estimated Primary Completion Date : December 18, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Perioperative ctDNA Dynamic Monitoring Group
Samples were obtained at multiple pre-specified time points including before surgery (plasma samples)，during surgery after tumor resection (tumor samples) and after surgery(plasma samples were obtained every 6 months from ctDNA positive patients at baseline in the following 2 years)
 Diagnostic Test: Perioperative ctDNA Dynamic Monitoring
To apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline


Outcome Measures
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Primary Outcome Measures :
  1. Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA [ Time Frame: 2 years after the last patient enrolled ]
    PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline.

  2. ctDNA dynamic monitoring [ Time Frame: 2 years after the last patient enrolled ]
    PEAC technology was performed to apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline


Biospecimen Retention:   Samples With DNA
Tumor Tissue, Whole Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stage I to III Non-Small Cell Lung Cancer (NSCLC) with R0 resection
Criteria

Inclusion Criteria:

  • Postoperative histopathological diagnosis of TNM stage I to III NSCLC with R0 resection;
  • No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery;
  • Men or women of age ≥18 years and <75 years old;
  • Eastern Cooperative Oncology Group (ECOG) behavior status score 0 to 1.

Exclusion Criteria:

  • Patients with other cancers other than NSCLC within five years prior to this study;
  • Who can not get enough tumor histological specimens (non-cytological) for analysis;
  • Human immunodeficiency virus (HIV) infection;
  • NSCLC mixed with patients with small cell lung cancer;
  • Pregnant or lactating women;
  • There is a clear history of neurological or mental disorders, including epilepsy or dementia;
  • Conditions that investigators think is not suitable for inclusion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238130


Contacts
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Contact: Si-Yu Wang, MD +86 20 87343439 wsysums@163.net

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Si-Yu Wang, Doctor    +86 20 87343439    wsysums@163.net   
Principal Investigator: Si-Yu Wang, Professor         
Sponsors and Collaborators
Sun Yat-sen University
Hangzhou Repugene Technology Co., Ltd.
Investigators
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Principal Investigator: Si-Yu Wang, MD Sun Yat-sen University
More Information
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Responsible Party: Si-Yu Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04238130    
Other Study ID Numbers: GASTO1058
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Si-Yu Wang, Sun Yat-sen University:
Non-Small Cell Lung Cancer (NSCLC)
Resectable
Dynamic Monitoring
PEAC
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms