Non Small Cell Lung CancerKINDNCT04676321
Key Performance Indicators for the Assessment of NSCLC Patients Pathway
An observational study of Non Small Cell Lung Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 3 sites in Italy.
Trial summary
This is a multicenter, observational study involving a retrospective collection of data. A total of potential 16 key performance indicators (KPIs) had been developed from a panel of experts (clinicians, IT experts, etc..) to investigate the appropriateness of care in NSCLC patients, with a special focus on the use of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Patient pathway
- How many people
- 430 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Oct 2020to 15 Nov 2020
- 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: The study population consisted of all adult patients (aged ≥ 18 years) residing in Emilia-Romagna region, identified in the Hospital discharge card, who has been discharged in any one of the participating sites (hospitals of Modena, Reggio-Emilia and Forlì-Cesena provinces) with a newly diagnosis of Non small cell lung cancer between January and December 2017.
Who may be able to join
- patients identified from hospital administrative databases of Emilia-Romagna region using a case selection algorithm for identifying Non small cell lung cancer
Who cannot join
- patients not residing in Emilia Romagna region (due to the difficulty in obtaining the medical data).
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
IRST
Meldola, Forlì-Cesena, 47014
Policlinico of Modena
Modena, 41125
IRCCS Arcispedale S.Maria Nuova
Reggio Emilia, RE, 42123
About this study
Official title: Key Performance Indicators for the Assessment of Diagnostic and Therapeutic Pathway of NSCLC Patients: a Multicenter Study (KIND NSCLC)
This is a multicenter, observational study involving a retrospective collection of data. A total of potential 16 key performance indicators (KPIs) had been developed from a panel of experts (clinicians, IT experts, etc..) to investigate the appropriateness of care in NSCLC patients, with a special focus on the use of immunotherapy. The eligible population and data will be gathered retrospectively using an algorithm. Administrative databases will be used as unique resource: to identify target population and to collect patient's data with which measure KPIs.
Read the detailed description
This is a multi-center, observational study involving retrospective collection of NSCLC patients information. All consecutive patients who had a newly diagnosis of NSCLC in 2017 from healthcare administrative database between January 2017 and December 2017, identified through the proposed algorithm, will be considered. All data needed for KPI calculation, even if they fall outside January-December 2017 period, will be collected. The end of data collection will be defined as patient death or 30 June 2018, whichever came first.
A set of potential KPIs had been developed from a panel of experts (clinicians, IT experts etc..) to investigate the appropriateness of activities within NSCLC care pathway, with a special focus on the use of immunotherapy. The following KPIs will be measured to investigate the appropriateness of NSCLC patient care pathways, with a special focus on the use of immunotherapy:
- Percentage of patients who performed biopsy within 7 days from the date of examination prescription;
- Percentage of metastatic NSCLC patients at diagnosis;
- Percentage of major surgical resections within the year of analysis;
- Percentage of surgical patients on the total number of patients with exploratory thoracotomy in inpatient setting;
- Percentage of patients undergoing neoadjuvant therapy ( CT or CT+RT within 6 months prior to the first major resection date;
- 30-day mortality rate from major surgery;
- Percentage of patients discussed in the multidisciplinary team (MDT) meeting at least once in the year of incidence;
- Percentage of patients who performed imaging exams such as MRI, TC and PET within 7 days from MDT meeting;
- Average and range of length of stay;
- Average time between biopsy and the first administration of systematic anti-cancer drug;
- Percentage of patients treated with immunotherapies;
- Percentage of patients who underwent immunotherapy for more than 6 months after first dose;
- Percentage of patients who underwent anti-cancer drug treatment in the last 30 days of life;
- Percentage of patients who underwent the first administration of systematic anticancer drug within 30 days from discussed in MDT meeting;
- Percentage of patients who underwent RT in the last 30 days of life ( excluded palliative treatments single fraction);
- Percentage of patients who underwent at least one Integrated Home Care (IHC);
- Percentage of patients who underwent at least one hospice care;
The eligible population and data will be gathered retrospectively through an algorithm from administrative databases (Hospital discharge cards, pharmaceutical databases as FED and AFT - direct and territorial distribution, the regional register of mortality REM, the regional register of outpatient specialist medical procedure ASA, the integrated home care IHC, and SDHS-hospice). Administrative data will be used as unique resource to identify patients cohort and to measure KPIs along care pathway. An evaluation of the NSCLC patients selection algorithm will be performed on a sub-population using the electronic health record EHR as gold standard.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Patient pathway
- Keywords
- lung cancer, NSCLC, Administrative databases, Algorithm
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient pathwayOther
Investigation on the appropriateness and quality of NSCLC care among participating sites
What is being measured
The primary outcome is the main question the study is designed to answer.
Key Performance indicators
To measure a set of potential indicators (KPIs) derived from administrative database in order to investigate the appropriateness and quality of NSCLC care among participating sites.
Measured: six months
Secondary outcomes (1)
Algorithm evaluatation
The secondary outcome is to develop and evaluate an algorithm to identify the eligible population of the study from administrative databases against to a clinical database. Algorithm will be used to identify study eligible patients and measure KPIs from hospital administrative databases.
Measured: two month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Oct 2020
- Primary completion15 Oct 2020
- Study completion15 Nov 2020
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 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
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, Azienda Ospedaliera Universitaria Policlinico
- Responsible party
- Principal investigator, oriana nanni, Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Investigators
- Mattia Altini, Master, Principal investigator, IRST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676321
- Sponsor's protocol ID
- IRST 162.13
- Acronym
- KIND
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Balzi W, Roncadori A, Danesi V, Massa I, Manunta S, Gentili N, Delmonte A, Crino L, Altini M. How to discriminate non-small cell lung cancer (NSCLC) cases from an Italian administrative database? A retrospective, secondary data use study for evaluating a novel algorithm performance. BMJ Open. 2021 Sep 24;11(9):e048188. doi: 10.1136/bmjopen-2020-048188.
PubMed 34561258
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Performance Indicators for the Assessment of Diagnostic and Therapeutic Pathway of NSCLC Patients: a Multicenter Study (KIND NSCLC)
- ClinicalTrials.gov ID
- NCT04676321
- Acronym / sponsor ID
- KIND / IRST 162.13
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- lung cancer, NSCLC, Administrative databases, Algorithm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, Azienda Ospedaliera Universitaria Policlinico
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 21 Dec 2020 (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 multicenter, observational study involving a retrospective collection of data. A total of potential 16 key performance indicators (KPIs) had been developed from a panel of experts (clinicians, IT experts, etc..) to investigate the appropriateness of care in NSCLC patients, with a special focus on the use of immunotherapy. The eligible population and data will be gathered retrospectively using an algorithm. Administrative databases will be used as unique resource: to identify target population and to collect patient's data with which measure KPIs.
Detailed description
This is a multi-center, observational study involving retrospective collection of NSCLC patients information. All consecutive patients who had a newly diagnosis of NSCLC in 2017 from healthcare administrative database between January 2017 and December 2017, identified through the proposed algorithm, will be considered. All data needed for KPI calculation, even if they fall outside January-December 2017 period, will be collected. The end of data collection will be defined as patient death or 30 June 2018, whichever came first.
A set of potential KPIs had been developed from a panel of experts (clinicians, IT experts etc..) to investigate the appropriateness of activities within NSCLC care pathway, with a special focus on the use of immunotherapy. The following KPIs will be measured to investigate the appropriateness of NSCLC patient care pathways, with a special focus on the use of immunotherapy:
- Percentage of patients who performed biopsy within 7 days from the date of examination prescription;
- Percentage of metastatic NSCLC patients at diagnosis;
- Percentage of major surgical resections within the year of analysis;
- Percentage of surgical patients on the total number of patients with exploratory thoracotomy in inpatient setting;
- Percentage of patients undergoing neoadjuvant therapy ( CT or CT+RT within 6 months prior to the first major resection date;
- 30-day mortality rate from major surgery;
- Percentage of patients discussed in the multidisciplinary team (MDT) meeting at least once in the year of incidence;
- Percentage of patients who performed imaging exams such as MRI, TC and PET within 7 days from MDT meeting;
- Average and range of length of stay;
- Average time between biopsy and the first administration of systematic anti-cancer drug;
- Percentage of patients treated with immunotherapies;
- Percentage of patients who underwent immunotherapy for more than 6 months after first dose;
- Percentage of patients who underwent anti-cancer drug treatment in the last 30 days of life;
- Percentage of patients who underwent the first administration of systematic anticancer drug within 30 days from discussed in MDT meeting;
- Percentage of patients who underwent RT in the last 30 days of life ( excluded palliative treatments single fraction);
- Percentage of patients who underwent at least one Integrated Home Care (IHC);
- Percentage of patients who underwent at least one hospice care;
The eligible population and data will be gathered retrospectively through an algorithm from administrative databases (Hospital discharge cards, pharmaceutical databases as FED and AFT - direct and territorial distribution, the regional register of mortality REM, the regional register of outpatient specialist medical procedure ASA, the integrated home care IHC, and SDHS-hospice). Administrative data will be used as unique resource to identify patients cohort and to measure KPIs along care pathway. An evaluation of the NSCLC patients selection algorithm will be performed on a sub-population using the electronic health record EHR as gold standard.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of all adult patients (aged ≥ 18 years) residing in Emilia-Romagna region, identified in the Hospital discharge card, who has been discharged in any one of the participating sites (hospitals of Modena, Reggio-Emilia and Forlì-Cesena provinces) with a newly diagnosis of Non small cell lung cancer between January and December 2017.
Key inclusion criteria (1 listed)
- patients identified from hospital administrative databases of Emilia-Romagna region using a case selection algorithm for identifying Non small cell lung cancer
Key exclusion criteria (1 listed)
- patients not residing in Emilia Romagna region (due to the difficulty in obtaining the medical data).
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 |
|---|---|---|
| Patient pathwayInvestigation on the appropriateness and quality of NSCLC care among participating sites | Other | – |
Primary outcome
Key Performance indicators
Time frame: six months
To measure a set of potential indicators (KPIs) derived from administrative database in order to investigate the appropriateness and quality of NSCLC care among participating sites.
1 secondary outcome
Algorithm evaluatation
Time frame: two month
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 Dec 2020.
- Derived from this study: PubMed 34561258Balzi W, Roncadori A, Danesi V, Massa I, Manunta S, Gentili N, Delmonte A, Crino L, Altini M. How to discriminate non-small cell lung cancer (NSCLC) cases from an Italian administrative database? A retrospective, secondary data use study for evaluating a novel algorithm performance. BMJ Open. 2021 Sep 24;11(9):e048188. doi: 10.1136/bmjopen-2020-048188.
- 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.
Mattia Altini, Master principal investigator
IRST
3 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 Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 3 sites in Italy.
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 1 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 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Key Performance indicators (time frame: six months). 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 NCT04676321, 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 21 Dec 2020.