NSCLCNCT03465241
ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage II to IIIA NSCLC by NGS
An observational study of NSCLC, run by Sun Yat-sen University at 1 site in China.
Trial summary
The second generation of high-throughput gene sequencing (NGS) is an important means of detecting the tumor DNA and circulating tumor DNA (ctDNA), which can detect trace ctDNA from smaller plasma samples. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- the ctDNA dynamic monitoring
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2017to 1 Feb 2021
- 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 IIA to IIIA Non-small Cell Lung Cancer (NSCLC) with R0 resection.
Who may be able to join
- Postoperative histopathological diagnosis of TNM stage IIA to IIIA NSCLC with R0 resection;
- No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer；
- 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: Prospective, Open Clinical Study of Postoperative ctDNA Dynamic Monitoring and Its Role of Prognosis in Patients With Stage II to IIIA Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)
The second generation of high-throughput gene sequencing (NGS) is an important means of detecting the tumor DNA and circulating tumor DNA (ctDNA), which can detect trace ctDNA from smaller plasma samples. This project is chiefly to study the role of ctDNA dynamic monitoring of stage IIA to IIIA NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA. And the investigators also wander the concordance of lung cancer related genes mutation map and frequency between primary tumors and infiltrated regional lymph nodes.
Read the detailed description
In the NGS era, ctDNA detection can truly reflect the real tumor tissue gene mutation map and frequency. It becomes the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after surgery and adjuvant chemotherapy. The second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. The DNA dynamic monitoring of stage II to IIIA non-small cell lung cancer (NSCLC) was performed by the NGS technique to verify prognostic predictive effect of ctDNA in stage IIA to IIIA NSCLC patients after operation. The lung cancer related genes mutation map and frequency between primary tumors and infiltrated regional lymph nodes seems not exactly consistent. In this study, the investigators will compare the lung cancer related genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node by the NGS technique.
- Conditions
- NSCLC
- Being tested
- the ctDNA dynamic monitoring
- Keywords
- Non-Small Cell Lung Cancer, stage II to IIIA, circulating tumor DNA, The next generation of high-throughput gene sequencing
- 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.
the ctDNA dynamic monitoringDiagnostic test
To detect ctDNA in patients using the second generation of high-throughput gene sequencing (NGS)
| Study group | Role | What they receive |
|---|---|---|
| Monitoring by NGS group | This group will accept the ctDNA dynamic monitoring on the following phase:the day before surgery,the 3rd to 7th day after surgery,3 to 4 weeks after adjuvant chemotherapy finished, then every 6 months in the following 2 years. Receives: Diagnostic Test: the ctDNA dynamic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease-free survival was assessed from surgery to disease recurrence or death as a result of any cause
Measured: 2 years after the last patient enrolled
Secondary outcomes (1)
the genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node
we will compare the lung cancer related genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node by the NGS technique.
Measured: one month 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 posted14 Mar 2018
- Study start21 Oct 2017
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- 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
- NCT03465241
- Sponsor's protocol ID
- GASTO1035
- Status last verified
- Jul 2021
- First submitted
- 7 Mar 2018
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li N, Wang BX, Li J, Shao Y, Li MT, Li JJ, Kuang PP, Liu Z, Sun TY, Wu HQ, Ou W, Wang SY. Perioperative circulating tumor DNA as a potential prognostic marker for operable stage I to IIIA non-small cell lung cancer. Cancer. 2022 Feb 15;128(4):708-718. doi: 10.1002/cncr.33985. Epub 2021 Oct 18.
PubMed 35076939
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Clinical Study of Postoperative ctDNA Dynamic Monitoring and Its Role of Prognosis in Patients With Stage II to IIIA Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)
- ClinicalTrials.gov ID
- NCT03465241
- Acronym / sponsor ID
- GASTO1035
- Conditions
- NSCLC
- Keywords
- Non-Small Cell Lung Cancer, stage II to IIIA, circulating tumor DNA, The next generation of high-throughput gene sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 21 Oct 2017 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 14 Mar 2018 (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.
The second generation of high-throughput gene sequencing (NGS) is an important means of detecting the tumor DNA and circulating tumor DNA (ctDNA), which can detect trace ctDNA from smaller plasma samples. This project is chiefly to study the role of ctDNA dynamic monitoring of stage IIA to IIIA NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA. And the investigators also wander the concordance of lung cancer related genes mutation map and frequency between primary tumors and infiltrated regional lymph nodes.
Detailed description
In the NGS era, ctDNA detection can truly reflect the real tumor tissue gene mutation map and frequency. It becomes the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after surgery and adjuvant chemotherapy. The second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. The DNA dynamic monitoring of stage II to IIIA non-small cell lung cancer (NSCLC) was performed by the NGS technique to verify prognostic predictive effect of ctDNA in stage IIA to IIIA NSCLC patients after operation. The lung cancer related genes mutation map and frequency between primary tumors and infiltrated regional lymph nodes seems not exactly consistent. In this study, the investigators will compare the lung cancer related genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node by the NGS technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring by NGS group | – | Diagnostic Test: the ctDNA dynamic monitoringThis group will accept the ctDNA dynamic monitoring on the following phase:the day before surgery,the 3rd to 7th day after surgery,3 to 4 weeks after adjuvant chemotherapy finished, then every 6 months 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 IIA to IIIA Non-small Cell Lung Cancer (NSCLC) with R0 resection.
Key inclusion criteria (3 listed)
- Postoperative histopathological diagnosis of TNM stage IIA to IIIA NSCLC with R0 resection;
- No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer；
- 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 |
|---|---|---|
| the ctDNA dynamic monitoringTo detect ctDNA in patients using the second generation of high-throughput gene sequencing (NGS) | Diagnostic test | Monitoring by NGS group |
Primary outcome
Disease-free survival
Time frame: 2 years after the last patient enrolled
Disease-free survival was assessed from surgery to disease recurrence or death as a result of any cause
1 secondary outcome
the genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node
Time frame: one month after the last patient enrolled
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 30 Jul 2021.
- Derived from this study: PubMed 35076939Li N, Wang BX, Li J, Shao Y, Li MT, Li JJ, Kuang PP, Liu Z, Sun TY, Wu HQ, Ou W, Wang SY. Perioperative circulating tumor DNA as a potential prognostic marker for operable stage I to IIIA non-small cell lung cancer. Cancer. 2022 Feb 15;128(4):708-718. doi: 10.1002/cncr.33985. Epub 2021 Oct 18.
- Individual participant dataSharing planned: No
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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 NSCLC, 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 3 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 30 Jul 2021. 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?
Disease-free survival (time frame: 2 years after the last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465241, which also lists 1 linked publication.
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 30 Jul 2021.