Lung CancerNCT03421093
A Study to Evaluate Clinical Characteristics of Lung Cancer in Patients With Surgeries and Adjuvant Therapies
An observational study of Lung Cancer, run by West China Hospital at 10 sites in China.
Trial summary
The study was designed to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 21,777 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lung malignant tumors who were performed with surgeries
Who may be able to join
- Age >= 18 years old;
- Pathologically diagnosed lung malignant tumors after surgeries;
- Patients with lung surgeries;
- Patients with complete medical health records and follow-up visit information (at least one follow-up visit);
Who cannot join
- Patients who were not performed with surgeries;
- Pathologically diagnosed patients with benign diseases after surgeries;
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 PLA General Hospital
Beijing, Beijing Municipality, 100853
West China Hospital, 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
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051
Tongji Hospital Affiliated to Huaxi Technology University
Wuhan, Hubei, 430030
Xi'an Tangdu Hospital
Xi'an, Shaanxi, 710000
Henan cancer hospital
Zhengzhou, Henan, 450008
About this study
Official title: A Multi-centre Real-world Non-interventional Observational Study to Evaluate Clinical Characteristics of the Chinese Patients With Lung Malignant Tumors Who Received Surgeries or Surgeries Plus Adjuvant Therapies
The study was designed to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors
Read the detailed description
The trial is a multi-centre real-world non-interventional observational study to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors via a retrospectively review method on the study data on patient demographic/tumor biological characteristics and clinical treatments.
- Conditions
- Lung Cancer
- Being tested
- Surgeries
- Keywords
- Lung cancer, Chinese, surgeries, adjuvant therapies
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeriesProcedure or surgery
Also called Adjuvant therapies
Surgeries or surgeries plus adjuvant therapies
| Study group | Role | What they receive |
|---|---|---|
| Surgeries and adjuvant therapies | Surgeries or surgeries plus adjuvant therapies Receives: Procedure: Surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic characteristics of the patients with lung malignant tumors who received surgeries
Demographic characteristics of the patients with lung malignant tumors who received surgeries of thoracotomy, video-assistant thoracic surgery or robotic thoracic surgery as measured by:
- Age
- Gender
- Payment types
- Insurance types
- Smoking history
- Complications and symptoms of complications
- Respiratory functions
- Type of diagnoses
Measured: 2014 - 2017
Secondary outcomes (3)
Location of tumors and tumor sizes
Location of tumors and tumor sizes
Measured: 2014 - 2017
Tumor clinical/pathological staging
Tumor clinical/pathological staging
Measured: 2014 - 2017
Type of biomarkers
Type of biomarkers
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 posted5 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.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by West China 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
- 21,777 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Principal investigator, Lunxu Liu, West China Hospital
- Investigators
- Lunxun Liu, PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421093
- Sponsor's protocol ID
- TSCI-4
- Status last verified
- May 2018
- First submitted
- 29 Dec 2017
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Evaluate Clinical Characteristics of the Chinese Patients With Lung Malignant Tumors Who Received Surgeries or Surgeries Plus Adjuvant Therapies
- ClinicalTrials.gov ID
- NCT03421093
- Acronym / sponsor ID
- TSCI-4
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Chinese, surgeries, adjuvant therapies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,777 participants (actual)
- Lead sponsor
- West China 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
- 5 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.
The study was designed to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors
Detailed description
The trial is a multi-centre real-world non-interventional observational study to evaluate effectiveness of the surgeries and adjuvant therapies after surgeries in the patients with lung malignant tumors via a retrospectively review method on the study data on patient demographic/tumor biological characteristics and clinical treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgeries and adjuvant therapies | – | Procedure: SurgeriesSurgeries or surgeries plus adjuvant therapies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung malignant tumors who were performed with surgeries
Key inclusion criteria (4 listed)
- Age >= 18 years old;
- Pathologically diagnosed lung malignant tumors after surgeries;
- Patients with lung surgeries;
- Patients with complete medical health records and follow-up visit information (at least one follow-up visit);
Key exclusion criteria (2 listed)
- Patients who were not performed with surgeries;
- Pathologically diagnosed patients with benign diseases after surgeries;
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 |
|---|---|---|
| SurgeriesAlso: Adjuvant therapiesSurgeries or surgeries plus adjuvant therapies | Procedure or surgery | Surgeries and adjuvant therapies |
Primary outcome
Demographic characteristics of the patients with lung malignant tumors who received surgeries
Time frame: 2014 - 2017
Demographic characteristics of the patients with lung malignant tumors who received surgeries of thoracotomy, video-assistant thoracic surgery or robotic thoracic surgery as measured by: * Age * Gender * Payment types * Insurance types * Smoking history * Complications and symptoms of complications * Respiratory functions * Type of diagnoses
3 secondary outcomes
Location of tumors and tumor sizes
Time frame: 2014 - 2017
Tumor clinical/pathological staging
Time frame: 2014 - 2017
Type of biomarkers
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.
- Individual participant dataSharing planned: Undecided
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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.
Lunxun Liu, PhD principal investigator
West China 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 Lung Cancer, run by West China 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 4 inclusion and 2 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?
Demographic characteristics of the patients with lung malignant tumors who received surgeries (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 21 May 2018.