Non-Small Cell Lung CancerEVOLUTIONNCT04238130
Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following Resection
An observational study of Non-Small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Perioperative ctDNA Dynamic Monitoring
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2019to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage I to III Non-Small Cell Lung Cancer (NSCLC) with R0 resection
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Perioperative Dynamic Changes in ctDNA From Patients of Non-Small-Cell Lung Cancer Following Resection for Relapse Prediction
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Perioperative ctDNA Dynamic Monitoring
- Keywords
- Non-Small Cell Lung Cancer (NSCLC), Resectable, Dynamic Monitoring, PEAC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative ctDNA Dynamic MonitoringDiagnostic test
To apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Perioperative ctDNA Dynamic Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA
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.
Measured: 2 years after the last patient enrolled
ctDNA dynamic monitoring
PEAC technology was performed to apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline
Measured: 2 years after the last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start18 Dec 2019
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Repugene Technology Co., Ltd.
- Responsible party
- Principal investigator, Si-Yu Wang, Sun Yat-sen University
- Investigators
- Si-Yu Wang, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238130
- Sponsor's protocol ID
- GASTO1058
- Acronym
- EVOLUTION
- Status last verified
- Dec 2024
- First submitted
- 17 Jan 2020
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Perioperative Dynamic Changes in ctDNA From Patients of Non-Small-Cell Lung Cancer Following Resection for Relapse Prediction
- ClinicalTrials.gov ID
- NCT04238130
- Acronym / sponsor ID
- EVOLUTION / GASTO1058
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer (NSCLC), Resectable, Dynamic Monitoring, PEAC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Repugene Technology Co., Ltd.
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perioperative ctDNA Dynamic Monitoring Group | – | Diagnostic Test: Perioperative ctDNA Dynamic MonitoringSamples 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage I to III Non-Small Cell Lung Cancer (NSCLC) with R0 resection
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative ctDNA Dynamic MonitoringTo apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline | Diagnostic test | Perioperative ctDNA Dynamic Monitoring Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Si-Yu Wang, MD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.