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

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

Tracking Information

• First Submitted Date: January 17, 2020
• First Posted Date: January 23, 2020
• Last Update Posted Date: February 5, 2020
• Actual Study Start Date: December 18, 2019
• Estimated Primary Completion Date: December 18, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 17, 2020)

• 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.
• 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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following Resection
• Official Title: Evaluation Perioperative Dynamic Changes in ctDNA From Patients of Non-Small-Cell Lung Cancer Following Resection for Relapse Prediction
• 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.
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Tumor Tissue, Whole Blood

• Sampling Method: Non-Probability Sample
• Study Population: Patients with stage I to III Non-Small Cell Lung Cancer (NSCLC) with R0 resection
• Condition: Non-Small Cell Lung Cancer

Intervention

Diagnostic Test: Perioperative ctDNA Dynamic Monitoring

To apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline

Study Groups/Cohorts

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)

Intervention: Diagnostic Test: Perioperative ctDNA Dynamic Monitoring

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 17, 2020): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2023
• Estimated Primary Completion Date: December 18, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04238130
• Other Study ID Numbers: GASTO1058
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Si-Yu Wang, Sun Yat-sen University
• Original Responsible Party: Same as current
• Current Study Sponsor: Sun Yat-sen University
• Original Study Sponsor: Same as current
• Collaborators: Hangzhou Repugene Technology Co., Ltd.

Investigators

• Principal Investigator: Si-Yu Wang, MD; Sun Yat-sen University

• PRS Account: Sun Yat-sen University
• Verification Date: January 2020