Value-Based Medicine (VBM) for Lung Cancer

NCT06703866 | Recruiting

• 1 other identifier: IEO 1399
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (1)

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

Other: Non Small Cell Lung Cancer (NSCLC)

Interventions

Non Small Cell Lung Cancer (NSCLC) OTHER

Application of "value based medicine" predictive model

Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with first diagnosis of non-small cell lung carcinoma eligible for surgical lung resection and available for follow up

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Monica Casiraghi

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Casiraghi

CONTACT

+39 02 57489425; monica.casiraghi@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: November 25, 2024
• Study Start: January 27, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-03

Locations

IT (1)