Non-small Cell Lung CancerNCT04266691
Analysis of Driver Gene Mutation in Early Stage Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Zhejiang Cancer Hospital.
Trial summary
Analysis of driver gene variation in early stage non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- nonIntervention
- How many people
- 237 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically or cytologically proven diagnosis of early stage NSCLC
Who may be able to join
- Female or male, 18 years of age or older
- Histologically or cytologically proven diagnosis of early stage NSCLC
- The lesion was completely resected by radical surgery
- Able to get tumor tissue sample
- Complete information of clinicopathological , survival, recurrence and metastasis can be obtained through follow-up
Who cannot join
- Combine with other tumor type
- The investigator judges the situation that may affect the clinical search process and results
About this study
Official title: Molecular Metastasis in Lymph Nodes is Associated With Survival of Patients With Stage I NSCLC
Analysis of driver gene variation in early stage non-small cell lung cancer
Read the detailed description
Fluorescence quantitative polymerase chain reaction (PCR) was used to detect the variation of driver gene in regional lymph nodes of early stage non-small cell lung cancer (NSCLC), and to analyze the relationship between the variation and disease recurrence and survival prognosis. evaluate the effect of the variation of driving gene in lymph nodes of early stage NSCLC on prognosis, identify the high-risk factors that promote the recurrence and metastasis of early stage tumor. so as to improve the diagnosis and treatment path of lung cancer, provide important pathological basis for the clinical diagnosis and treatment of early stage non-small cell lung cancer, enable patients to receive more accurate treatment, and improve their survival prognosis.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- nonIntervention
- Keywords
- Regional Lymph nodes, Molecular metastasis, Driver gene mutation
- 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.
nonInterventionOther
nonIntervention
| Study group | Role | What they receive |
|---|---|---|
| Driver gene mutation-positive | Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a driver gene mutation positive. Receives: Other: nonIntervention | |
| Driver gene mutation-negative | Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a driver gene mutation negative. Receives: Other: nonIntervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driver gene mutation frequency of early stage NSCLC
Observe the driver gene mutation frequency in regional lymph nodes of early stage non-small cell lung cancer
Measured: 2019
Correlation of Clinicopathological characteristics and driver gene mutation in regional lymph nodes of early stage NSCLC
Analyze the correlation between driver gene mutation and clinicopathological features in regional lymph nodes of early stage NSCLC
Measured: 2019
Correlation between driver gene mutation and survival prognosis in regional lymph nodes of early stage NSCLC
Observe the correlation between driver gene mutation and survival prognosis in regional lymph nodes of early stage NSCLC
Measured: 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study startJan 2009
- Primary completionDec 2015
- Study completionJun 2019
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 CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- Retrospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zjszlyyad@126.com, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266691
- Sponsor's protocol ID
- LN-OMs
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tian Y, Lai Q, Zheng Y, Ying L, Wang C, Jin J, Huang M, Wu Y, Li H, Zhang J, Su D. Oncogenic Alterations in Histologically Negative Lymph Nodes Are Associated with Prognosis of Patients with Stage I Lung Adenocarcinoma. Cancers (Basel). 2022 Feb 6;14(3):824. doi: 10.3390/cancers14030824.
PubMed 35159091
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Metastasis in Lymph Nodes is Associated With Survival of Patients With Stage I NSCLC
- ClinicalTrials.gov ID
- NCT04266691
- Acronym / sponsor ID
- LN-OMs
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Regional Lymph nodes, Molecular metastasis, Driver gene mutation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 12 Feb 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.
Analysis of driver gene variation in early stage non-small cell lung cancer
Detailed description
Fluorescence quantitative polymerase chain reaction (PCR) was used to detect the variation of driver gene in regional lymph nodes of early stage non-small cell lung cancer (NSCLC), and to analyze the relationship between the variation and disease recurrence and survival prognosis. evaluate the effect of the variation of driving gene in lymph nodes of early stage NSCLC on prognosis, identify the high-risk factors that promote the recurrence and metastasis of early stage tumor. so as to improve the diagnosis and treatment path of lung cancer, provide important pathological basis for the clinical diagnosis and treatment of early stage non-small cell lung cancer, enable patients to receive more accurate treatment, and improve their survival prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Driver gene mutation-positive | – | Other: nonInterventionScreen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a driver gene mutation positive. |
| Driver gene mutation-negative | – | Other: nonInterventionScreen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a driver gene mutation negative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically or cytologically proven diagnosis of early stage NSCLC
Key inclusion criteria (5 listed)
- Female or male, 18 years of age or older
- Histologically or cytologically proven diagnosis of early stage NSCLC
- The lesion was completely resected by radical surgery
- Able to get tumor tissue sample
- Complete information of clinicopathological , survival, recurrence and metastasis can be obtained through follow-up
Key exclusion criteria (2 listed)
- Combine with other tumor type
- The investigator judges the situation that may affect the clinical search process and results
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 |
|---|---|---|
| nonInterventionnonIntervention | Other | Driver gene mutation-negative, Driver gene mutation-positive |
Primary outcome
Driver gene mutation frequency of early stage NSCLC
Time frame: 2019
Observe the driver gene mutation frequency in regional lymph nodes of early stage non-small cell lung cancer
Correlation of Clinicopathological characteristics and driver gene mutation in regional lymph nodes of early stage NSCLC
Time frame: 2019
Analyze the correlation between driver gene mutation and clinicopathological features in regional lymph nodes of early stage NSCLC
Correlation between driver gene mutation and survival prognosis in regional lymph nodes of early stage NSCLC
Time frame: 2019
Observe the correlation between driver gene mutation and survival prognosis in regional lymph nodes of early stage NSCLC
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 12 Feb 2020.
- Derived from this study: PubMed 35159091Tian Y, Lai Q, Zheng Y, Ying L, Wang C, Jin J, Huang M, Wu Y, Li H, Zhang J, Su D. Oncogenic Alterations in Histologically Negative Lymph Nodes Are Associated with Prognosis of Patients with Stage I Lung Adenocarcinoma. Cancers (Basel). 2022 Feb 6;14(3):824. doi: 10.3390/cancers14030824.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Zhejiang Cancer Hospital.
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 2 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Driver gene mutation frequency of early stage NSCLC (time frame: 2019). The study lists 3 primary outcomes in all. 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 NCT04266691, 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 12 Feb 2020.