Non-small Cell Lung CancerNCT03429192
A Study to Explore Clinical Characteristics and Prognoses of N2 Patients With Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Tianjin Chest Hospital at 9 sites in China.
Trial summary
A study to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases 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?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,653 participants
- Where
- 9 sitesChina
- Study dates
- 1 Dec 2017to 30 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pathologically diagnosed Chinese NSCLC patients with chest surgeries and lymphadenectomy
Who may be able to join
- Patients with surgeries from 2014 to 2017;
- Pathologically diagnosed patients with non-small cell lung cancer;
- Age > 18 years old;
- Patients with chest surgeries before hospitalization;
- Patients with N2 lymph nodes (+) after surgeries who received lymphadenectomy (Group 10 and 11 lymph nodes);
Who cannot join
- Patients with radiotherapies, chemotherapies and biological therapies for tumors
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
China People's Liberation Army Hospital
Beijing, Beijing Municipality, 100853
Huaxi Hospital Affiliate to Sichuan University
Chengdu, Sichuan, 610041
First Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, 310003
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Tongji Hospital Affiliated to Huaxi Technology University
Wuhan, Hubei, 430030
Xi'an Tangdu Hospital
Xi'an, Shanghai Municipality, 710000
Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: A Multi-centre Real-world Non-interventional Observational Study to Explore Clinical Characteristics of Lymph Skip Metastases and Prognoses of N2 Patients With Non-small Cell Lung Cancer
A study to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases
Read the detailed description
A multi-centre real-world non-interventional observational study to retrospectively collect the study data on patient demographic/tumor biological characteristics and clinical treatments to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Surgery
- Keywords
- Chinese, real-world evidences, NSCLC, lymph skip metastases
- 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.
SurgeryProcedure or surgery
Surgeries plus dissection of lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| N2 non-small cell lung cancer | Chinese patients with N2 non-small cell lung cancer Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in overall survival (OS)
OS difference in the subgroups of N2 patients with lymph skip metastases and non-skip metastases
Measured: 2014 - 2017
Secondary outcomes (1)
Percentage of N2 patients with lymph skip metastases
Percentage of N2 patients with lymph skip metastases
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 posted12 Feb 2018
- Study start1 Dec 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
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.
- 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
- 2,653 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Principal investigator, Lingyu Huang, Tianjin Chest Hospital
- Investigators
- Xun Zhang, PhD, Principal investigator, Tianjin Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429192
- Sponsor's protocol ID
- TJ-N2LC-01
- Status last verified
- May 2018
- First submitted
- 5 Feb 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Li X, Fu X, Liu L, Liu Y, Zhao H, Li Y, Hu J, Xu L, Liu D, Yang H, Zhang X. Survival benefit of skip metastases in surgically resected N2 non-small cell lung cancer: A multicenter observational study of a large cohort of the Chinese patients. Eur J Surg Oncol. 2020 Oct;46(10 Pt A):1874-1881. doi: 10.1016/j.ejso.2019.12.015. Epub 2019 Dec 18.
PubMed 31902592
Study at a glance
From the registry record, last updated by the sponsor on 21 May 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 Clinical Characteristics of Lymph Skip Metastases and Prognoses of N2 Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03429192
- Acronym / sponsor ID
- TJ-N2LC-01
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Chinese, real-world evidences, NSCLC, lymph skip metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,653 participants (actual)
- Lead sponsor
- Tianjin Chest HospitalUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 12 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.
A study to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases
Detailed description
A multi-centre real-world non-interventional observational study to retrospectively collect the study data on patient demographic/tumor biological characteristics and clinical treatments to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N2 non-small cell lung cancer | – | Procedure: SurgeryChinese patients with N2 non-small cell lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathologically diagnosed Chinese NSCLC patients with chest surgeries and lymphadenectomy
Key inclusion criteria (5 listed)
- Patients with surgeries from 2014 to 2017;
- Pathologically diagnosed patients with non-small cell lung cancer;
- Age > 18 years old;
- Patients with chest surgeries before hospitalization;
- Patients with N2 lymph nodes (+) after surgeries who received lymphadenectomy (Group 10 and 11 lymph nodes);
Key exclusion criteria (1 listed)
- Patients with radiotherapies, chemotherapies and biological therapies for tumors
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 |
|---|---|---|
| SurgerySurgeries plus dissection of lymph nodes | Procedure or surgery | N2 non-small cell lung cancer |
Primary outcome
Difference in overall survival (OS)
Time frame: 2014 - 2017
OS difference in the subgroups of N2 patients with lymph skip metastases and non-skip metastases
1 secondary outcome
Percentage of N2 patients with lymph skip metastases
Time frame: 2014 - 2017
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 21 May 2018.
- Derived from this study: PubMed 31902592Li X, Li X, Fu X, Liu L, Liu Y, Zhao H, Li Y, Hu J, Xu L, Liu D, Yang H, Zhang X. Survival benefit of skip metastases in surgically resected N2 non-small cell lung cancer: A multicenter observational study of a large cohort of the Chinese patients. Eur J Surg Oncol. 2020 Oct;46(10 Pt A):1874-1881. doi: 10.1016/j.ejso.2019.12.015. Epub 2019 Dec 18.
- 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.
Xun Zhang, PhD principal investigator
Tianjin Chest Hospital
9 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 Tianjin Chest Hospital at 9 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 5 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: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
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?
Difference in overall survival (OS) (time frame: 2014 - 2017). 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 NCT03429192, 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 21 May 2018.