Non-small Cell Lung CancerNCT03710629
A Study to Explore Treatment Regimens and Clinical Outcomes of the NSCLC Patients With Different Dirver Genes
An observational study of Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
A single-center, non-interventional prospective observational study in the NSCLC patients with different driver genes 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?
- Patients with driver genes
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 Dec 2022
- 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: The pathologically diagnosed patients with non-small cell lung cancer who were performed with NGS technology
Who may be able to join
- The patients with lung cancer who were performed with next-generation sequencing (NGS) technology from 2015 to 2017;
- The patients who were at least 18 years;
- The pathologically diagnosed patients with non-small cell lung cancer (NSCLC)
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenhua of Liang
Guangzhou, Guangdong, 510120
Wenhua o Liang, Ph.D, 00862083062114 ext. 00862083062114, liangwh1987@163.com
About this study
Official title: A Prospective Observational Study to Explore Treatment Regimens and Clinical Outcomes of the NSCLC Patients With Different Driver Genes
A single-center, non-interventional prospective observational study in the NSCLC patients with different driver genes
Read the detailed description
The trial was designed as a single-center non-interventional prospective observational study to explore clinical treatments of the NSCLC patients with different driver genes, the impact factors of patient survivals, and the relevance of gene types, clinical treatments, and distribution of gene types. The follow-up visits, interactions between the investigators and patients, patient questionnaires/quality of life, and other patient information will be uploaded via mobile APP, and webchat every three months.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Patients with driver genes
- Keywords
- Non-small cell lung cancer, gene mutations
- 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.
Patients with driver genesOther
Patients with driver genes
| Study group | Role | What they receive |
|---|---|---|
| NSCLC patients with driver genes | NSCLC patients and driver genes Receives: Other: Patients with driver genes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in overall survival rates
Differences in overall survival rates of the NSCLC patients with various gene types
Measured: 2018-2022
Secondary outcomes (7)
Interaction impact between gene types and treatment modalities or regimens on disease-free survivals
Interaction impact between gene types and treatment modalities or regimens on disease-free survivals
Measured: 2018-2022
Statuses of clinical treatment regimens
Statuses of clinical treatment regimens of the NSCLC patients
Measured: 2018-2022
Relevance of gene types
Relevance of gene types and clinical characteristics of the NSCLC patients
Measured: 2018-2022
Relevance of overall survival rates and gene types
Relevance of overall survival rates and gene types of the NSCLC patients
Measured: 2018-2022
Impacts of disease-free survivals on gene types
Impacts of disease-free survivals on gene types of the NSCLC patients
Measured: 2018-2022
Impacts of progression-free survivals
Impacts of progression-free survivals on gene types of the NSCLC patients
Measured: 2018-2022
Impact factors of overall survivals
Impact factors of overall survivals of the NSCLC patients
Measured: 2018-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Jul 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
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 The First Affiliated Hospital of Guangzhou Medical 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
- 750 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Wenhua Liang, Ph.D, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710629
- Sponsor's protocol ID
- GZH-Gene
- Status last verified
- Oct 2018
- First submitted
- 10 Jul 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Explore Treatment Regimens and Clinical Outcomes of the NSCLC Patients With Different Driver Genes
- ClinicalTrials.gov ID
- NCT03710629
- Acronym / sponsor ID
- GZH-Gene
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, gene mutations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 18 Oct 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.
A single-center, non-interventional prospective observational study in the NSCLC patients with different driver genes
Detailed description
The trial was designed as a single-center non-interventional prospective observational study to explore clinical treatments of the NSCLC patients with different driver genes, the impact factors of patient survivals, and the relevance of gene types, clinical treatments, and distribution of gene types. The follow-up visits, interactions between the investigators and patients, patient questionnaires/quality of life, and other patient information will be uploaded via mobile APP, and webchat every three months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC patients with driver genes | – | Other: Patients with driver genesNSCLC patients and driver genes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The pathologically diagnosed patients with non-small cell lung cancer who were performed with NGS technology
Key inclusion criteria (3 listed)
- The patients with lung cancer who were performed with next-generation sequencing (NGS) technology from 2015 to 2017;
- The patients who were at least 18 years;
- The pathologically diagnosed patients with non-small cell lung cancer (NSCLC)
Key exclusion criteria (1 listed)
- -None
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 |
|---|---|---|
| Patients with driver genesPatients with driver genes | Other | NSCLC patients with driver genes |
Primary outcome
Differences in overall survival rates
Time frame: 2018-2022
Differences in overall survival rates of the NSCLC patients with various gene types
7 secondary outcomes
Interaction impact between gene types and treatment modalities or regimens on disease-free survivals
Time frame: 2018-2022
Statuses of clinical treatment regimens
Time frame: 2018-2022
Relevance of gene types
Time frame: 2018-2022
Relevance of overall survival rates and gene types
Time frame: 2018-2022
Impacts of disease-free survivals on gene types
Time frame: 2018-2022
Impacts of progression-free survivals
Time frame: 2018-2022
Impact factors of overall survivals
Time frame: 2018-2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- 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.
Wenhua Liang, Ph.D principal investigator
The First Affiliated Hospital of Guangzhou Medical 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 The First Affiliated Hospital of Guangzhou Medical 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 1 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: status not confirmed, as of the sponsor's last update on 18 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianxing HE, MD (00862083062114, hejx@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in overall survival rates (time frame: 2018-2022). 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 18 Oct 2018.