Value-Based Medicine (VBM) for Lung Cancer

NCT ID: NCT06703866

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-27

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Non Small Cell Lung Cancer (NSCLC)

Intervention Type OTHER

Application of "value based medicine" predictive model

Interventions

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Non Small Cell Lung Cancer (NSCLC)

Application of "value based medicine" predictive model

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patients with benign lesion
* Patients with recurrence who have already undergone lung surgery
* Conditions/pathologies that prevent the ability to give consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monica Casiraghi

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

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European Institute of Oncology

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Monica Casiraghi

Role: CONTACT

+39 02 57489425

Facility Contacts

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Monica Casiraghi

Role: primary

Other Identifiers

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IEO 1399

Identifier Type: -

Identifier Source: org_study_id

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