Central Lung CancerNCT05278754
Independent Predictors Analysis and Model Construction of Cavitary Central Lung Cancer
An observational study of Central Lung Cancer, run by The Central Hospital of Lishui City.
Trial summary
This study is a retrospective, multicenter clinical study. The main goal is to identify the risk factors for cavity formation in central-type lung cancer lesions, and to construct a prediction model for cavity formation in central-type lung cancer lesions based on the above risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Lung Cancer
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2022to 12 Aug 2022
- 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: This is a multicenter study. Patients from Lishui Central Hospital of Zhejiang Province, the Second Affiliated Hospital of Medical College of Zhejiang University, and Affiliated Hospital of Xinjiang Medical University who meet the above criteria will be included in this study
Who may be able to join
- Age：older than 18 years；
- Clinical or pathologically confirmed central lung cancer;
- Lesions without cavities at first diagnosis of central lung cancer;
- Performed complete laboratory and imaging research at the first diagnosis of the central lung cancer;
- Patients with cavities formation during follow up, and the cavities were independently confirmed by at least 3 imaging experts;
- Patients with complete medical records;
Who cannot join
- Patients suffering other malignant tumors;
- Patients missing the imaging data;
- Patients missing the clinical data.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Independent Predictors Analysis and Model Construction of Cavitary Central Lung Cancer: a Retrospective, Multicenter Trial
This study is a retrospective, multicenter clinical study. The main goal is to identify the risk factors for cavity formation in central-type lung cancer lesions, and to construct a prediction model for cavity formation in central-type lung cancer lesions based on the above risk factors.
- Conditions
- Central Lung Cancer
- Keywords
- Central Lung Cancer, Cavity, Predictor
What is being measured
The primary outcome is the main question the study is designed to answer.
Formation of cavities in the central lung cancer, assessed up to 18 months.
Time from enrollment to the time of cavities formation, assessed up to 18 months.
Measured: Time from enrollment to the time of cavities formation, assessed up to 18 months.
Secondary outcomes (1)
Hemoptysis in patients with central lung cancer, assessed up to 18 months.
Time from enrollment to hemoptysis, assessed up to 18 months.
Measured: Time from enrollment to hemoptysis, assessed up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start12 Mar 2022 (estimated)
- Primary completion12 May 2022 (estimated)
- Study completion12 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Central Hospital of Lishui City
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278754
- Sponsor's protocol ID
- ZJLS-KLDMIR-22004
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Statistical analysis plan, informed consent form, and clinical study report can be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Predictors Analysis and Model Construction of Cavitary Central Lung Cancer: a Retrospective, Multicenter Trial
- ClinicalTrials.gov ID
- NCT05278754
- Acronym / sponsor ID
- ZJLS-KLDMIR-22004
- Conditions
- Central Lung Cancer
- Keywords
- Central Lung Cancer, Cavity, Predictor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Central Hospital of Lishui CityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Affiliated Hospital of Xinjiang Medical University
- Study start
- 12 Mar 2022 (estimated)
- Primary completion
- 12 May 2022 (estimated)
- Study completion
- 12 Aug 2022 (estimated)
- First posted
- 14 Mar 2022 (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.
This study is a retrospective, multicenter clinical study. The main goal is to identify the risk factors for cavity formation in central-type lung cancer lesions, and to construct a prediction model for cavity formation in central-type lung cancer lesions based on the above risk factors.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a multicenter study. Patients from Lishui Central Hospital of Zhejiang Province, the Second Affiliated Hospital of Medical College of Zhejiang University, and Affiliated Hospital of Xinjiang Medical University who meet the above criteria will be included in this study
Key inclusion criteria (6 listed)
- Age：older than 18 years；
- Clinical or pathologically confirmed central lung cancer;
- Lesions without cavities at first diagnosis of central lung cancer;
- Performed complete laboratory and imaging research at the first diagnosis of the central lung cancer;
- Patients with cavities formation during follow up, and the cavities were independently confirmed by at least 3 imaging experts;
Key exclusion criteria (3 listed)
- Patients suffering other malignant tumors;
- Patients missing the imaging data;
- Patients missing the clinical data.
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
Formation of cavities in the central lung cancer, assessed up to 18 months.
Time frame: Time from enrollment to the time of cavities formation, assessed up to 18 months.
Time from enrollment to the time of cavities formation, assessed up to 18 months.
1 secondary outcome
Hemoptysis in patients with central lung cancer, assessed up to 18 months.
Time frame: Time from enrollment to hemoptysis, assessed up to 18 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: Yes. Statistical analysis plan, informed consent form, and clinical study report can be shared with other researchers.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Lung Cancer, run by The Central Hospital of Lishui City.
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 6 inclusion and 3 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 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Jianfei Tu, Dr (13646782878, jianfei1133@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Formation of cavities in the central lung cancer, assessed up to 18 months. (time frame: Time from enrollment to the time of cavities formation, assessed up to 18 months.). 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 14 Mar 2022.