Advanced Non-small Cell Lung CancerNCT03334864
Observational Cohort Study of Advanced Non-small Cell Lung Cancer (CAPTRA-LUNG)
An observational study of Advanced Non-small Cell Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Investigators propose to establish and maintain a cohort of patients with advanced non-small cell lung cancer, and to assess the treatment pattern, host genetic, and clinical factors which influence the prognosis and survival, as well as the interaction among these factors on disease diagnosis and treatment, short and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2022to Dec 2025
- How long will I take part?
- 3 Years
- 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: 5000 advanced NSCLC patients
Who may be able to join
- Cohort I: diagnosis of advanced non-small cell lung cancer from 2012-2016;
- Cohort II: documented positive driver gene mutations; and diagnosis of advanced non-small cell lung cancer;
- Cohort III: diagnosis of advanced non-small cell lung cancer and in immune-therapy;
- Cohort IV: diagnosis of advanced non-small cell lung cancer, and with wild-type driver gene or unknown driver gene status;
- Cohort V: treated with anti-VEGF drug in first line, diagnosis of advanced non-squamous and non-small cell lung cancer in 6 months before recruit;
- Age>18 years;
- Provision of written informed consent.
Who cannot join
- not applicable
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yan Xu, Dr.
About this study
Investigators propose to establish and maintain a cohort of patients with advanced non-small cell lung cancer, and to assess the treatment pattern, host genetic, and clinical factors which influence the prognosis and survival, as well as the interaction among these factors on disease diagnosis and treatment, short and long-term outcomes.
Study type: Observational (Patient Registry)
Study design: Observational Model: Cohort
Time Perspective: Prospective and retrospective
- Conditions
- Advanced Non-small Cell Lung Cancer
- Keywords
- Advanced non-small cell lung cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| I Retrospective cohort | Diagnosis of advanced non-small cell lung cancer from 2012-2016 | |
| II Prospective cohort | Advanced non-small cell lung cancer with driver gene mutations | |
| III Prospective cohort | Non-small cell lung cancer in immuno-therapy; | |
| IV Prospective cohort | Non-small cell lung cancer with wild-type driver gene or unknown driver gene status; | |
| V Prospective cohort | Advanced non-small lung cancer with wild-type gene treated with anti-Vascular Endothelial Growth Factor (VEGF) drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS was calculated from the diagnosis of advanced non-small cell lung cancer to death from any reasons
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start3 Nov 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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 Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334864
- Sponsor's protocol ID
- JS-1410
- Status last verified
- Nov 2022
- First submitted
- 31 Oct 2017
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu Y, Zhang L, Fang J, Wang Z, Li J, Li L, Ai B, Nie L, Mu X, Liang L, Zhang S, Zhang Y, Song Y, Song X, Wang Y, Xin T, Jin B, Wang X, Ding C, Wang M. Establishment of a prospective multicenter cohort for advanced non-small cell lung cancer in China (CAPTRA-Lung study). Thorac Cancer. 2018 Dec;9(12):1795-1800. doi: 10.1111/1759-7714.12865. Epub 2018 Sep 27.
PubMed 30264504
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study of Advanced Non-small Cell Lung Cancer (CAPTRA-LUNG)
- ClinicalTrials.gov ID
- NCT03334864
- Acronym / sponsor ID
- JS-1410
- Conditions
- Advanced Non-small Cell Lung Cancer
- Keywords
- Advanced non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Nov 2017 (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.
Investigators propose to establish and maintain a cohort of patients with advanced non-small cell lung cancer, and to assess the treatment pattern, host genetic, and clinical factors which influence the prognosis and survival, as well as the interaction among these factors on disease diagnosis and treatment, short and long-term outcomes.
Study type: Observational (Patient Registry)
Study design: Observational Model: Cohort
Time Perspective: Prospective and retrospective
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| I Retrospective cohort | – | –Diagnosis of advanced non-small cell lung cancer from 2012-2016 |
| II Prospective cohort | – | –Advanced non-small cell lung cancer with driver gene mutations |
| III Prospective cohort | – | –Non-small cell lung cancer in immuno-therapy; |
| IV Prospective cohort | – | –Non-small cell lung cancer with wild-type driver gene or unknown driver gene status; |
| V Prospective cohort | – | –Advanced non-small lung cancer with wild-type gene treated with anti-Vascular Endothelial Growth Factor (VEGF) drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 5000 advanced NSCLC patients
Key inclusion criteria (7 listed)
- Cohort I: diagnosis of advanced non-small cell lung cancer from 2012-2016;
- Cohort II: documented positive driver gene mutations; and diagnosis of advanced non-small cell lung cancer;
- Cohort III: diagnosis of advanced non-small cell lung cancer and in immune-therapy;
- Cohort IV: diagnosis of advanced non-small cell lung cancer, and with wild-type driver gene or unknown driver gene status;
- Cohort V: treated with anti-VEGF drug in first line, diagnosis of advanced non-squamous and non-small cell lung cancer in 6 months before recruit;
Key exclusion criteria (1 listed)
- not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: 3 years
OS was calculated from the diagnosis of advanced non-small cell lung cancer to death from any reasons
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 30264504Xu Y, Zhang L, Fang J, Wang Z, Li J, Li L, Ai B, Nie L, Mu X, Liang L, Zhang S, Zhang Y, Song Y, Song X, Wang Y, Xin T, Jin B, Wang X, Ding C, Wang M. Establishment of a prospective multicenter cohort for advanced non-small cell lung cancer in China (CAPTRA-Lung study). Thorac Cancer. 2018 Dec;9(12):1795-1800. doi: 10.1111/1759-7714.12865. Epub 2018 Sep 27.
- 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.
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 Advanced Non-small Cell Lung Cancer, run by Peking Union Medical College Hospital 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 7 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 11 Sep 2023. 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 Yan Xu, M.D. (861069155039, maraxu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 3 years). 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 NCT03334864, 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 11 Sep 2023.