Non-small Cell Lung CancerNCT03710616
A Real-world Study to Explore Recurrence/Metastases of the NSCLC Patients and the Impact Factors of Patient Survivals
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
The real-world study was designed to explore recurrence/metastases of the patients with non-small cell lung cancer as measured by patient survivals and the impact factors of patient survivals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2018to 1 Jan 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pathologically diagnosed early-stage (I-IIIA) NSCLC patients who were operated with radical operations of the lung cancer
Who may be able to join
- The patients who meet all the following inclusion criteria will be included in the study:
- The patients who were operated with radical operations of the lung cancer;
- The patients with clinical I-IIIA staging tumors;
- The pathologically diagnosed NSCLC patients;
Who cannot join
- Not be specified;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou
Wenhua Liang, PhD, 0086-20-83062114, liangwh1987@163.com
Wenhua Liang, PhD
About this study
Official title: A Real-world Study to Explore Recurrence/Metastases of the Early-stage (I-IIIA) NSCLC Patients and the Impact Factors of Patient Survivals
The real-world study was designed to explore recurrence/metastases of the patients with non-small cell lung cancer as measured by patient survivals and the impact factors of patient survivals.
Read the detailed description
The trial was designed as a real-world observational study to recruit those patients with pathologically diagnosed early-phase non-small cell lung cancer (NSCLC) who were enrolled in the clinical form 2009 to 2017 and explore recurrence/metastases of the NSCLC patients as measured by patient survivals and the impact factors of patient survivals. The study data on patient demographic characteristics, tumor biological characteristics, and clinicla treatments were collected via a retrospectively review method for evaluation of patient survivals and the relevance of clinical characteristics of the patients and patient survivals.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Surgeries
- Keywords
- early-stage NSCLC, real-world evidences, patient survivals
- 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.
SurgeriesProcedure or surgery
Surgical operations plus systematic lymphadenectomies
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival rates within the configured observation periods
Disease-free survival rates within 3-month, 6-month, 1-year, 2-year, and 3-year observation periods;
Measured: 2009-2017
Secondary outcomes (1)
Disease-free survival rates at the configured locations and observation periods
Disease-free survival rates at the metastasized lymph nodes, bone, and brain within 3-month, 6-month, 1-year, 2-year, and 3-year observation periods;
Measured: 2009-2017
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 start24 Mar 2018
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Jan 2023 (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
- Retrospective
- Enrolment
- 700 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
- NCT03710616
- Sponsor's protocol ID
- GZH-001
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2018
- Last updated
- 1 Aug 2019
- 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 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study to Explore Recurrence/Metastases of the Early-stage (I-IIIA) NSCLC Patients and the Impact Factors of Patient Survivals
- ClinicalTrials.gov ID
- NCT03710616
- Acronym / sponsor ID
- GZH-001
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- early-stage NSCLC, real-world evidences, patient survivals
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 24 Mar 2018 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (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.
The real-world study was designed to explore recurrence/metastases of the patients with non-small cell lung cancer as measured by patient survivals and the impact factors of patient survivals.
Detailed description
The trial was designed as a real-world observational study to recruit those patients with pathologically diagnosed early-phase non-small cell lung cancer (NSCLC) who were enrolled in the clinical form 2009 to 2017 and explore recurrence/metastases of the NSCLC patients as measured by patient survivals and the impact factors of patient survivals. The study data on patient demographic characteristics, tumor biological characteristics, and clinicla treatments were collected via a retrospectively review method for evaluation of patient survivals and the relevance of clinical characteristics of the patients and patient survivals.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pathologically diagnosed early-stage (I-IIIA) NSCLC patients who were operated with radical operations of the lung cancer
Key inclusion criteria (4 listed)
- The patients who were operated with radical operations of the lung cancer;
- The patients with clinical I-IIIA staging tumors;
- The pathologically diagnosed NSCLC patients;
Key exclusion criteria (1 listed)
- Not be specified;
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 |
|---|---|---|
| SurgeriesSurgical operations plus systematic lymphadenectomies | Procedure or surgery | – |
Primary outcome
Disease-free survival rates within the configured observation periods
Time frame: 2009-2017
Disease-free survival rates within 3-month, 6-month, 1-year, 2-year, and 3-year observation periods;
1 secondary outcome
Disease-free survival rates at the configured locations and observation periods
Time frame: 2009-2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- 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 4 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 1 Aug 2019. 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 (0086-20-83062114, hejx@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival rates within the configured observation periods (time frame: 2009-2017). 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 1 Aug 2019.