Non-small Cell Lung Cancer Stage INCT03172156
ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS
An observational study of Non-small Cell Lung Cancer Stage I, run by Sun Yat-sen University at 1 site in China.
Trial summary
CtDNA detection is a noninvasive detection method, and 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage I
- What is being tested?
- ctDNA detection
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 Feb 2020
- 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 Non-small Cell Lung Cancer (NSCLC) without Postoperative radiotherapy and chemotherapy
Who may be able to join
- Postoperative histopathological diagnosis of TNM stage IA / IB NSCLC with R0 resection;
- No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery;
- General selection criteria:
- Men or women of age ≥18 years and <75 years old;
- 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: Multicentre, Prospective, Open Clinical Study of Postoperative ctDNA Dynamic Monitoring and Its Role of Prognosis in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)
CtDNA detection is a noninvasive detection method, and 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. This project is to study the role of ctDNA dynamic monitoring of stage I NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA .
Read the detailed description
CtDNA detection as a noninvasive detection method, can truly reflect the real tumor tissue gene mutation map and frequency, is the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after treatment. 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 ctDNA dynamic monitoring of stage I non-small cell lung cancer (NSCLC) was performed by the second generation gene sequencing (NGS) technique to verify the prognostic predictive effect of ctDNA in stage I NSCLC patients without radiotherapy and targeted therapy.
- Conditions
- Non-small Cell Lung Cancer Stage I
- Being tested
- ctDNA detection
- Keywords
- NSCLC, stage I, The next generation of high-throughput gene sequencing (NGS), ctDNA
- 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.
ctDNA detectionGenetic
To detect ctDNA in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)
| Study group | Role | What they receive |
|---|---|---|
| Stage I NSCLC patients after surgery with ctDNA detection | Stage I NSCLC patients;ctDNA detection Receives: Genetic: ctDNA detection |
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)
Overall survival
Overall survival was assessed from surgery to death as a result of any cause
Measured: 5 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 posted1 Jun 2017
- Study start1 Jul 2017
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
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 Non-small Cell Lung Cancer Stage IStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Si-Yu Wang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172156
- Sponsor's protocol ID
- GASTO1018
- Status last verified
- Sep 2024
- First submitted
- 29 May 2017
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators will not share IPD to other researchers until initial experimental conclusions is reached.
Publications
Yang W, You N, Jia M, Yeung SJ, Ou W, Yu M, Wang Y, Fu X, Zhang Z, Yang J, Lao Z, Liu Z, Zeng B, Ou Q, Wu X, Shao YW, Hong X, Wang S, Cheng C. Undetectable circulating tumor DNA levels correlate with low risk of recurrence/metastasis in postoperative pathologic stage I lung adenocarcinoma patients. Lung Cancer. 2020 Aug;146:327-334. doi: 10.1016/j.lungcan.2020.06.009. Epub 2020 Jun 20.
PubMed 32623075
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Prospective, Open Clinical Study of Postoperative ctDNA Dynamic Monitoring and Its Role of Prognosis in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)
- ClinicalTrials.gov ID
- NCT03172156
- Acronym / sponsor ID
- GASTO1018
- Conditions
- Non-small Cell Lung Cancer Stage I
- Keywords
- NSCLC, stage I, The next generation of high-throughput gene sequencing (NGS), ctDNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 1 Jun 2017 (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.
CtDNA detection is a noninvasive detection method, and 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. This project is to study the role of ctDNA dynamic monitoring of stage I NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA .
Detailed description
CtDNA detection as a noninvasive detection method, can truly reflect the real tumor tissue gene mutation map and frequency, is the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after treatment. 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 ctDNA dynamic monitoring of stage I non-small cell lung cancer (NSCLC) was performed by the second generation gene sequencing (NGS) technique to verify the prognostic predictive effect of ctDNA in stage I NSCLC patients without radiotherapy and targeted therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage I NSCLC patients after surgery with ctDNA detection | – | Genetic: ctDNA detectionStage I NSCLC patients;ctDNA detection |
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 Non-small Cell Lung Cancer (NSCLC) without Postoperative radiotherapy and chemotherapy
Key inclusion criteria (5 listed)
- Postoperative histopathological diagnosis of TNM stage IA / IB 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;
- 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 |
|---|---|---|
| ctDNA detectionTo detect ctDNA in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS) | Genetic | Stage I NSCLC patients after surgery with ctDNA detection |
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
Overall survival
Time frame: 5 years 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 4 Sep 2024.
- Derived from this study: PubMed 32623075Yang W, You N, Jia M, Yeung SJ, Ou W, Yu M, Wang Y, Fu X, Zhang Z, Yang J, Lao Z, Liu Z, Zeng B, Ou Q, Wu X, Shao YW, Hong X, Wang S, Cheng C. Undetectable circulating tumor DNA levels correlate with low risk of recurrence/metastasis in postoperative pathologic stage I lung adenocarcinoma patients. Lung Cancer. 2020 Aug;146:327-334. doi: 10.1016/j.lungcan.2020.06.009. Epub 2020 Jun 20.
- Individual participant dataSharing planned: Undecided. The investigators will not share IPD to other researchers until initial experimental conclusions is reached.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stage I, 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 5 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 4 Sep 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?
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 NCT03172156, 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 4 Sep 2024.