Non Small Cell Lung CancerNCT03427541
A Study to Explore Prognoses of NSCLC Patients Complicated With Oligometastases
An observational study of Non Small Cell Lung Cancer, run by Tang-Du Hospital at 10 sites in China.
Trial summary
An observational study to explore prognoses and clinical treatments of the patients with non-small cell lung cancer complicated with oligometastases 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
- 1,000 participants
- Where
- 10 sitesChina
- Study dates
- 31 Dec 2017to 30 Apr 2018
- 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 patients with non-small cell lung cancer
Who may be able to join
- Pathologically diagnosed patients with non-small cell lung cancer;
- Tumor metastases in one organ (no more than 3 metastases);
Who cannot join
- Patients with intrapulmonary metastases or multiple primary tumors;
- Patients with pleural dissemination or invasion of extrapulmonary organs;
- Patients with supraclavicular lymph node metastasis;
- Patients with systematic diseases that would influence patient survivals;
- Patients with no records for visits;
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Deruo Liu, PhD, 0086-13801186957, deruoliu@vip.sina.com
Deruo Liu, PhD
- Recruiting
China PLA General Hospital
Beijing, Beijing Municipality, 100853
Yang Liu, PhD, 0086-13501009331, sunny301x@sina.com
Yang Liu, PhD
- Recruiting
Huaxi Hospital Affiliated to Sichuan University
Chengdu, Sichuan, 610041
Lunxu Liu, PhD, 0086-13608236600, lunxu_liu@aliyun.com
Lunxu Liu, PhD
- Recruiting
First Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, 310003
Jian Hu, PhD, 0086-13605708283, hujian_med@163.com
Jian Hu, PhD
- Recruiting
Jiangsu cancer hospital
Nanjing, Jiangsu, 210009
Lin Xu, PhD, 0086-13605168383, xulin83@vip.sina.com
Lin Xu, PhD
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Heng Zhao, PhD, 0086-13701865603, h_zhao28@163.com
Heng Zhao, PhD
- Recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051
Xun Zhang, PhD, 0086-18602212679, zhangxun69@163.com
Xun Zhang, PhD
- Recruiting
Tongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, 430030
Xiangning Fu, PhD, 0086-13607150390, Fuxn2006@aliyun.com
Xiangning Fu, PhD
- Recruiting
Xi'an Tangdu Hospital
Xi'an, Shaanxi, 710000
Xiaofei Fu, PhD, 0086-15009266699, lxfchest@fmmu.edu.cn
Xiaofei Li, PhD
- Recruiting
Henan cancer hospital
Zhengzhou, Henan, 450008
Yin Li, PhD, 0086-13903838752, liyin825@aliyun.com
Yin Li, PhD
About this study
Official title: A Multi-centre Real-world Non-interventional Observational Study to Explore Prognoses of the Patients With Non-small Cell Lung Cancer Complicated With Oligometastases
An observational study to explore prognoses and clinical treatments of the patients with non-small cell lung cancer complicated with oligometastases
Read the detailed description
A multi-centre real-world non-interventional observational study to explore prognoses and clinical treatments of the patients with non-small lung cancer complicated with oligometastases
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Surgeries
- Keywords
- Chinese, non-small cell lung cancer, oligometastases
- 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
Surgeries
| Study group | Role | What they receive |
|---|---|---|
| Patients with surgeries | NSCLC patients with surgeries Receives: Procedure: Surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: 2014 - 2017
Secondary outcomes (1)
Disease-free survival
Disease-free survival
Measured: 2014 - 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start31 Dec 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Apr 2018 (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 Tang-Du 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Principal investigator, Zhang Helong, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427541
- Sponsor's protocol ID
- WTONG05
- Status last verified
- Feb 2018
- First submitted
- 2 Feb 2018
- Last updated
- 9 Feb 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 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Real-world Non-interventional Observational Study to Explore Prognoses of the Patients With Non-small Cell Lung Cancer Complicated With Oligometastases
- ClinicalTrials.gov ID
- NCT03427541
- Acronym / sponsor ID
- WTONG05
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Chinese, non-small cell lung cancer, oligometastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 31 Dec 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 9 Feb 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.
An observational study to explore prognoses and clinical treatments of the patients with non-small cell lung cancer complicated with oligometastases
Detailed description
A multi-centre real-world non-interventional observational study to explore prognoses and clinical treatments of the patients with non-small lung cancer complicated with oligometastases
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with surgeries | – | Procedure: SurgeriesNSCLC patients with surgeries |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pathologically diagnosed patients with non-small cell lung cancer
Key inclusion criteria (2 listed)
- Pathologically diagnosed patients with non-small cell lung cancer;
- Tumor metastases in one organ (no more than 3 metastases);
Key exclusion criteria (5 listed)
- Patients with intrapulmonary metastases or multiple primary tumors;
- Patients with pleural dissemination or invasion of extrapulmonary organs;
- Patients with supraclavicular lymph node metastasis;
- Patients with systematic diseases that would influence patient survivals;
- Patients with no records for visits;
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 |
|---|---|---|
| SurgeriesSurgeries | Procedure or surgery | Patients with surgeries |
Primary outcome
Overall survival
Time frame: 2014 - 2017
Overall survival
1 secondary outcome
Disease-free survival
Time frame: 2014 - 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 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.
10 sites 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 Tang-Du Hospital at 10 sites 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 2 inclusion and 5 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 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 Haiying Yang, PhD (0086-010-62680809, celineyang@linkdoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2014 - 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 9 Feb 2018.