Non Small Cell Lung CancerNCT03413956
An Observational Study to Explore Clinical Characteristics of the Patients With T1 Non-small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by Jiangsu Cancer Institute & Hospital at 10 sites in China.
Trial summary
The real-world observational study was designed to explore the odd factors of lymph metastases in the patients with T1 non-small cell lung cancer, the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups. 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
- 10,885 participants
- Where
- 10 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The eligible subjects are the Chinese T1 patients with non-small cell lung cancer complicated with lymph metastases
Who may be able to join
- Patients who received surgeries from 2015 to 2017;
- Pathologically diagnosed patients with T1 non-small cell lung cancer;
Who cannot join
- Patients with tumor treatments (including chemotherapies, radiotherapies, biological therapies, intervention therapies)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
China People's Liberation Army Hospital
Beijing, Beijing Municipality, 100853
West China Hospital
Chengdu, Sichuan, 610041
First Hospital Affiliated to Medical College, Zhejiang University
Hangzhou, Zhejiang, 310006
Jiangsu Cancer Institute and Hospital
Nanjing, Jiangsu, 210009
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Tongji Hospital Affiliated to Tongji Medical College, Huaxi Technology University
Wuhan, Hubei, 430030
Xi'an Tangdu Hospital
Xi'an, Shaanxi, 710000
Henan cancer hospital
Zhengzhou, Henan, 450003
Henan Cancer Hospital
Zhengzhou, Henan
About this study
Official title: A Multi-centre Real-world Non-interventional Observational Study to Explore Clinical Characteristics of the Chinese Patients With T1 Non-small Cell Lung Cancer Complicated With Lymph Metastases
The real-world observational study was designed to explore the odd factors of lymph metastases in the patients with T1 non-small cell lung cancer, the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.
Read the detailed description
The trial is a multi-centre, real-world non-interventional observational study. In the study, the patients with T1 non-small cell lung cancer enrolled in clinics from 2015 to 2017 were included via a retrospectively review method and the study data on patient demographic/tumor biological characteristics, and clinical treatments were collected to explore the clinical odd factors of lymph metastases, evaluate the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Surgeries
- Keywords
- Chinese, T1 non-small cell lung cancer, Lymph 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.
SurgeriesProcedure or surgery
Surgeries
| Study group | Role | What they receive |
|---|---|---|
| NSCLC patients with lymph metastases | Pathologically diagnosed patients with T1 non-small cell lung cancer complicated with lymph metastases after surgeries Receives: Procedure: Surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the patients with lymph metastases
Percentages of the patients with lymph metastases categorised by patient demographic and tumor biological characteristics
Measured: 2015 - 2017
Secondary outcomes (1)
Percentages of N0/N1/N2/N3 patients
Percentages of N0/N1/N2/N3 patients in the target population
Measured: 2015 - 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 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.
- 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
- 10,885 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Jiang, Jiangsu Cancer Institute & Hospital
- Investigators
- Lin Xu, Principal investigator, Jiangsu Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413956
- Sponsor's protocol ID
- JS-LC-01
- Status last verified
- May 2018
- First submitted
- 15 Jan 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
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 the Chinese Patients With T1 Non-small Cell Lung Cancer Complicated With Lymph Metastases
- ClinicalTrials.gov ID
- NCT03413956
- Acronym / sponsor ID
- JS-LC-01
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Chinese, T1 non-small cell lung cancer, Lymph metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,885 participants (actual)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 29 Jan 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 observational study was designed to explore the odd factors of lymph metastases in the patients with T1 non-small cell lung cancer, the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.
Detailed description
The trial is a multi-centre, real-world non-interventional observational study. In the study, the patients with T1 non-small cell lung cancer enrolled in clinics from 2015 to 2017 were included via a retrospectively review method and the study data on patient demographic/tumor biological characteristics, and clinical treatments were collected to explore the clinical odd factors of lymph metastases, evaluate the effects of clinical characteristics on lymph metastases, and compare the differences in lymph metastases in the subgroups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC patients with lymph metastases | – | Procedure: SurgeriesPathologically diagnosed patients with T1 non-small cell lung cancer complicated with lymph metastases after surgeries |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The eligible subjects are the Chinese T1 patients with non-small cell lung cancer complicated with lymph metastases
Key inclusion criteria (2 listed)
- Patients who received surgeries from 2015 to 2017;
- Pathologically diagnosed patients with T1 non-small cell lung cancer;
Key exclusion criteria (1 listed)
- Patients with tumor treatments (including chemotherapies, radiotherapies, biological therapies, intervention therapies)
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 | NSCLC patients with lymph metastases |
Primary outcome
Percentage of the patients with lymph metastases
Time frame: 2015 - 2017
Percentages of the patients with lymph metastases categorised by patient demographic and tumor biological characteristics
1 secondary outcome
Percentages of N0/N1/N2/N3 patients
Time frame: 2015 - 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.
- 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.
Lin Xu principal investigator
Jiangsu Cancer Institute and Hospital
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 Jiangsu Cancer Institute & 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 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 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?
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?
Percentage of the patients with lymph metastases (time frame: 2015 - 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 21 May 2018.