Lung CancerLC PCCM QIPNCT06484972
A Study to Evaluate Guideline Adoption Through Quality Improvement Project (QIP) in Pulmonary and Critical Care Medicine (PCCM) Department
An observational study of Lung Cancer, run by China-Japan Friendship Hospital.
Trial summary
This is a cluster randomized controlled trial with PCCM department in each site being the cluster. Fifty-four sites' PCCM departments will be randomized to the QIP arm versus control arm in 2:1 allocation ratio. The QIP arm will perform QIP intervention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- How many people
- 1,728 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Pulmonologists in PCCM(Pulmonary and Critical Care Medicine).
- Cluster 1.1 Cluster inclusion criteria 1.1.1 PCCM department in Tier 3 hospital. 1.1.2 PCCM department's standardized construction certification is "qualified ". 1.1.3 PCCM department who want to improve lung cancer healthcare quality and agree to participate in study. 1.2 Cluster exclusion criteria 1.2.1 PCCM department does not carry out anti-tumor treatment for lung cancer. 1.2.2 PCCM department participant in other lung cancer quality improvement study.
- Individual Patient 2.1 Individual inclusion criteria 2.1.1 Pathology diagnosed NSCLC or ES-SCLC. 2.1.2 No prior systematic anti-tumor therapy, or prior adjuvant and neo-adjuvant therapies, definitive radiation/chemoradiation are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease.
2.1.3 Performance score (PS) 0-2. 2.1.4 Life expectancy >12 weeks. 2.2 Individual exclusion criteria 2.2.1 Have a plan to transfer to other hospitals to receive anti-tumor therapy within 3 months after signing the ICF.
2.2.2 Participating in another interventional clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Cluster Randomized Controlled Study to Evaluate Guideline Adoption Through Lung Cancer Clinical Care Quality Improvement Project (QIP) in Pulmonary and Critical Care Medicine (PCCM) Department
This is a cluster randomized controlled trial with PCCM department in each site being the cluster. Fifty-four sites' PCCM departments will be randomized to the QIP arm versus control arm in 2:1 allocation ratio. The QIP arm will perform QIP intervention. The control arm will not receive intervention and continue with usual care.
The primary endpoints of this study are molecular testing rate of non-small cell lung cancer (NSCLC) prior to the first systematic anti-tumor therapy, and adjuvant or first line targeted therapy treatment rate in actionable oncogenic alterations (AGA) NSCLC.
Read the detailed description
Approximately 1728 patients from 54 sites will be enrolled (about 30 NSCLC [20%-30% squamous cases] and 2 extensive-stage small-cell lung cancer [ES-SCLC] patients in each site). Patients in the QIP arm will be enrolled after about 3-month QIP intervention. Patients in the control arm will be enrolled as soon as the trial starts. Data on lung cancer diagnosis and treatment pattern will be collected.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
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 |
|---|---|---|
| Quality improvement project arm | The Quality improvement project(QIP) arm will perform QIP intervention. Patients in the QIP arm will be enrolled after about 3-month QIP intervention. The QIP interventions include: establish a coaching committee, quality improvement workshop, implementation of quality improvement measures, as well as evaluation periodically and feedback. | |
| Control arm | The control arm will not receive intervention and continue with usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular testing rate of NSCLC(Non-small cell lung cancer) prior to the first systematic anti-tumor therapy
The percentage of patients with a pathological diagnosis of NSCLC who undertake molecular testing prior to the first systematic anti-tumor therapy in patients with a pathological diagnosis of NSCLC.
Measured: Baseline, 3/6/12/21/30 months post enrollment
Adjuvant or first line targeted therapy treatment rate in AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer)
The percentage of patients with AGA NSCLC who receive adjuvant or first line targeted therapy in patients with AGA NSCLC who receive adjuvant or first line systematic therapy.
Measured: Baseline, 3/6/12/21/30 months post enrollment
Secondary outcomes (12)
TNM stage diagnosis rate prior to the first anti-tumor therapy
The percentage of patients with clinical TNM staging diagnosis before first anti-tumor treatment of lung cancer in patients with first anti-tumor treatment of lung cancer.
Measured: Baseline
Biopsy method
Describe the pathological biopsy method of lung cancer patients, including but not limited to bronchoscopy biopsy rate, percutaneous lung biopsy rate, thoracoscopic lung biopsy rate, etc.
Measured: Baseline, 3/6/12/21/30 months post enrollment
Spirometry rate
The percentage of patients with lung cancer who perform spirometry in patients with lung cancer.
Measured: Baseline
First line immunotherapy treatment rate in unresectable non-AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer)
The percentage of patients with unresectable non-AGA NSCLC who receive first line immunotherapy in patients with unresectable non-AGA NSCLC who receive the first systematic therapy.
Measured: Baseline, 3/6/12/21/30 months post enrollment
First line chemotherapy-immunotherapy treatment rate of ES-SCLC(Extensive-stage small-cell lung cancer) (stage III-IV)
The percentage of patients with ES-SCLC (stage III-IV) who receive first line chemotherapy-immunotherapy in patients with ES-SCLC (stage III-IV) who receive the first systematic therapy.
Measured: Baseline, 3/6/12/21/30 months post enrollment
Surgical rate of stage I-IIIA NSCLC(Non-small cell lung cancer)
The percentage of patients with stage I-IIIA NSCLC who undergo surgical resection in patients with stage I-IIIA NSCLC.
Measured: Baseline, 3/6/12/21/30 months post enrollment
MDT(Multi-disciplinary team) rate of stage IIIB-IV NSCLC(Non-small cell lung cancer)
The percentage of patients with stage IIIB-IV NSCLC discussed at the MDT meeting in patients with stage IIIB-IV NSCLC.
Measured: Baseline, 3/6/12/21/30 months post enrollment
ORR(Objective response rate) of stage IIIB-IV NSCLC(Non-small cell lung cancer)
ORR will be defined as the proportion of patients who achieved BOR of a CR or PR assessed by pulmonologists.
Measured: Baseline, 3/6/12/21/30 months post enrollment
ORR(Objective response rate) of ES-SCLC(Extensive-stage small-cell lung cancer)
ORR will be defined as the proportion of patients who achieved BOR of a CR or PR assessed by pulmonologists.
Measured: Baseline, 3/6/12/21/30 months post enrollment
PFS(Progression-free survival) of stage IIIB-IV NSCLC(Non-small cell lung cancer)
PFS will be defined as the time from beginning of first-line treatment to disease progression or death for any cause, whichever occurs first.
Measured: Baseline, 3/6/12/21/30 months post enrollment
PFS(Progression-free survival) of ES-SCLC(Extensive-stage small-cell lung cancer)
PFS will be defined as the time from beginning of first-line treatment to disease progression or death for any cause, whichever occurs first.
Measured: Baseline, 3/6/12/21/30 months post enrollment
DFS(Disease free survival) of NSCLC(Non-small cell lung cancer) who receive neoadjuvant/adjuvant therapy
DFS will be defined as the time from surgery to recurrence of tumor or death for any cause, whichever occurs first.
Measured: Baseline, 3/6/12/21/30 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Mar 2025 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Wang Chen, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484972
- Sponsor's protocol ID
- ESR-24-22776
- Acronym
- LC PCCM QIP
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 28 Jan 2025
- Results posted
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Cluster Randomized Controlled Study to Evaluate Guideline Adoption Through Lung Cancer Clinical Care Quality Improvement Project (QIP) in Pulmonary and Critical Care Medicine (PCCM) Department
- ClinicalTrials.gov ID
- NCT06484972
- Acronym / sponsor ID
- LC PCCM QIP / ESR-24-22776
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,728 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 3 Jul 2024 (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 is a cluster randomized controlled trial with PCCM department in each site being the cluster. Fifty-four sites' PCCM departments will be randomized to the QIP arm versus control arm in 2:1 allocation ratio. The QIP arm will perform QIP intervention. The control arm will not receive intervention and continue with usual care.
The primary endpoints of this study are molecular testing rate of non-small cell lung cancer (NSCLC) prior to the first systematic anti-tumor therapy, and adjuvant or first line targeted therapy treatment rate in actionable oncogenic alterations (AGA) NSCLC.
Detailed description
Approximately 1728 patients from 54 sites will be enrolled (about 30 NSCLC [20%-30% squamous cases] and 2 extensive-stage small-cell lung cancer [ES-SCLC] patients in each site). Patients in the QIP arm will be enrolled after about 3-month QIP intervention. Patients in the control arm will be enrolled as soon as the trial starts. Data on lung cancer diagnosis and treatment pattern will be collected.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quality improvement project arm | – | –The Quality improvement project(QIP) arm will perform QIP intervention. Patients in the QIP arm will be enrolled after about 3-month QIP intervention. The QIP interventions include: establish a coaching committee, quality improvement workshop, implementation of quality improvement measures, as well as evaluation periodically and feedback. |
| Control arm | – | –The control arm will not receive intervention and continue with usual care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pulmonologists in PCCM(Pulmonary and Critical Care Medicine).
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
Molecular testing rate of NSCLC(Non-small cell lung cancer) prior to the first systematic anti-tumor therapy
Time frame: Baseline, 3/6/12/21/30 months post enrollment
The percentage of patients with a pathological diagnosis of NSCLC who undertake molecular testing prior to the first systematic anti-tumor therapy in patients with a pathological diagnosis of NSCLC.
Adjuvant or first line targeted therapy treatment rate in AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer)
Time frame: Baseline, 3/6/12/21/30 months post enrollment
The percentage of patients with AGA NSCLC who receive adjuvant or first line targeted therapy in patients with AGA NSCLC who receive adjuvant or first line systematic therapy.
12 secondary outcomes
TNM stage diagnosis rate prior to the first anti-tumor therapy
Time frame: Baseline
Biopsy method
Time frame: Baseline, 3/6/12/21/30 months post enrollment
Spirometry rate
Time frame: Baseline
First line immunotherapy treatment rate in unresectable non-AGA(Actionable oncogenic alterations) NSCLC(Non-small cell lung cancer)
Time frame: Baseline, 3/6/12/21/30 months post enrollment
First line chemotherapy-immunotherapy treatment rate of ES-SCLC(Extensive-stage small-cell lung cancer) (stage III-IV)
Time frame: Baseline, 3/6/12/21/30 months post enrollment
Surgical rate of stage I-IIIA NSCLC(Non-small cell lung cancer)
Time frame: Baseline, 3/6/12/21/30 months post enrollment
MDT(Multi-disciplinary team) rate of stage IIIB-IV NSCLC(Non-small cell lung cancer)
Time frame: Baseline, 3/6/12/21/30 months post enrollment
ORR(Objective response rate) of stage IIIB-IV NSCLC(Non-small cell lung cancer)
Time frame: Baseline, 3/6/12/21/30 months post enrollment
ORR(Objective response rate) of ES-SCLC(Extensive-stage small-cell lung cancer)
Time frame: Baseline, 3/6/12/21/30 months post enrollment
PFS(Progression-free survival) of stage IIIB-IV NSCLC(Non-small cell lung cancer)
Time frame: Baseline, 3/6/12/21/30 months post enrollment
PFS(Progression-free survival) of ES-SCLC(Extensive-stage small-cell lung cancer)
Time frame: Baseline, 3/6/12/21/30 months post enrollment
DFS(Disease free survival) of NSCLC(Non-small cell lung cancer) who receive neoadjuvant/adjuvant therapy
Time frame: Baseline, 3/6/12/21/30 months post enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by China-Japan Friendship Hospital.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanhong Ren, M.D (+86 134 6638 0716, ryhong7561@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular testing rate of NSCLC(Non-small cell lung cancer) prior to the first systematic anti-tumor therapy (time frame: Baseline, 3/6/12/21/30 months post enrollment). The study lists 2 primary outcomes in all. 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 28 Jan 2025.