Lung CancerVBMNCT06703866
Value-Based Medicine (VBM) for Lung Cancer
An observational study of Lung Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
This is a prospective observational monocentric trial. The primary endpoint is the validation of predictive models. These predictive models will be used to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical… 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?
- Non Small Cell Lung Cancer (NSCLC)
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jan 2021to 31 Dec 2024
- 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 first diagnosis of non-small cell lung carcinoma eligible for surgical lung resection and available for follow up
Who may be able to join
- Patients aged ≥ 18 years
- Patients with diagnosis of non-small cell lung carcinoma
- Only patients eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy
- Diagnosis of primary non-small cell lung cancer
- Signed Informed Consent
- Patients must be available for follow-up
Who cannot join
- Patients with benign lesion
- Patients with recurrence who have already undergone lung surgery
- Conditions/pathologies that prevent the ability to give consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Monica Casiraghi
About this study
Official title: Validation of Predictive Model in Value-based Medicine for Lung Cancer and Analysis of Its Implications for Patient Communication
This is a prospective observational monocentric trial. The primary endpoint is the validation of predictive models. These predictive models will be used to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.
Read the detailed description
The goal of this prospective observational monocentric study is to validate a predictive models in patients with diagnosis of non-small cell lung cancer eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy.
Participants will be asked to complete quality of life questionnaires before surgery and then at 30 days, 4 months, 8 months and 12 months post discharge.
The informations collected through questionnaires, along with clinical data will be used to validate the predictive models created.
These models will then be utilized to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.
- Conditions
- Lung Cancer
- Being tested
- Non Small Cell Lung Cancer (NSCLC)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Small Cell Lung Cancer (NSCLC)Other
Application of "value based medicine" predictive model
| Study group | Role | What they receive |
|---|---|---|
| Non Small Cell Lung Cancer (NSCLC) | Patients with diagnosis of Non Small Cell Lung Cancer (NSCLC) eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy Receives: Other: Non Small Cell Lung Cancer (NSCLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a personalized clinical-functional risk profile
Developement of a personalized clinical-functional risk profile for estimating , prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.
The patient will be asked to complete questionnaires (EORTC QLQ-C30 / EORTC QLQ- LC13) on clinical-functional status and quality of life both before and after surgery, at 30 days, 4 months, 8 months and 12 months after discharge. The information acquired with the questionnaires, together with the clinical information acquired during the healthcare services, will be used to validate and refine the predictive models created and will be used to create a personalized clinical-functional risk profile.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start27 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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.
- More trials run by European Institute of OncologyThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica Casiraghi, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703866
- Sponsor's protocol ID
- IEO 1399
- Acronym
- VBM
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Predictive Model in Value-based Medicine for Lung Cancer and Analysis of Its Implications for Patient Communication
- ClinicalTrials.gov ID
- NCT06703866
- Acronym / sponsor ID
- VBM / IEO 1399
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Nov 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 prospective observational monocentric trial. The primary endpoint is the validation of predictive models. These predictive models will be used to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.
Detailed description
The goal of this prospective observational monocentric study is to validate a predictive models in patients with diagnosis of non-small cell lung cancer eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy.
Participants will be asked to complete quality of life questionnaires before surgery and then at 30 days, 4 months, 8 months and 12 months post discharge.
The informations collected through questionnaires, along with clinical data will be used to validate the predictive models created.
These models will then be utilized to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non Small Cell Lung Cancer (NSCLC) | – | Other: Non Small Cell Lung Cancer (NSCLC)Patients with diagnosis of Non Small Cell Lung Cancer (NSCLC) eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with first diagnosis of non-small cell lung carcinoma eligible for surgical lung resection and available for follow up
Key inclusion criteria (6 listed)
- Patients aged ≥ 18 years
- Patients with diagnosis of non-small cell lung carcinoma
- Only patients eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy
- Diagnosis of primary non-small cell lung cancer
- Signed Informed Consent
Key exclusion criteria (3 listed)
- Patients with benign lesion
- Patients with recurrence who have already undergone lung surgery
- Conditions/pathologies that prevent the ability to give consent
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 |
|---|---|---|
| Non Small Cell Lung Cancer (NSCLC)Application of "value based medicine" predictive model | Other | Non Small Cell Lung Cancer (NSCLC) |
Primary outcome
Creation of a personalized clinical-functional risk profile
Time frame: 12 months
Developement of a personalized clinical-functional risk profile for estimating , prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge. The patient will be asked to complete questionnaires (EORTC QLQ-C30 / EORTC QLQ- LC13) on clinical-functional status and quality of life both before and after surgery, at 30 days, 4 months, 8 months and 12 months after discharge. The information acquired with the questionnaires, together with the clinical information acquired during the healthcare services, will be used to validate and refine the predictive models created and will be used to create a personalized clinical-functional risk profile.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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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.
Monica Casiraghi principal investigator
European Institute of Oncology
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 Lung Cancer, run by European Institute of Oncology at 1 site 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 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 25 Nov 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Casiraghi (+39 02 57489425, monica.casiraghi@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a personalized clinical-functional risk profile (time frame: 12 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 25 Nov 2024.