NCT05802771

Brief Summary

The goal of this multi-centric observational clinical trial is to to develop accurate predictive models for lung cancer patients, through the creation of Digital Human Avatars using various omics-based variables and integrating well-established clinical factors with "big data" and advanced imaging features The main goals of LANTERN project are:

  • To develop prevention models for early lung cancer diagnosis;
  • To set up personalized predictive models for individual-specific treatments; Lung cancer patients will be prospectively enrolled and main omics data (including radiomics and genomics) will be collected, reflecting the main omics domains associated with the lung cancer diagnosis and decision making pathway. An exploratory analysis across all collected datasets will select a pool of potential biomarkers to create a multiple distinct multivariate models, trained though advanced machine learning (ML) and AI techniques sub-divided into specific areas of interest. Finally, the developed predictive models will be validated in order to test their robustness, transferability and generalizability, leading to the development of the Digital Human Avatar.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Jun 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jun 2023Jun 2026

First Submitted

Initial submission to the registry

February 16, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

April 7, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

February 16, 2023

Last Update Submit

April 4, 2023

Conditions

Non Small Cell Lung Cancer

Keywords

radiomicsNon small cell lung cancerbiomarkers

Outcome Measures

Primary Outcomes (1)

  • To develop prevention models for early lung cancer diagnosis

    Development of prognostic model in NSCLC patients using omics data. In particular, will be determinate the association between radiomics characteristics and biomarkers to lung cancer stage and survival outcome. Omics data and prognostic model will be tested in terms of disease free and overall survival comapring the different models.

    36 months

Study Arms (1)

enrolled patients

Non small cell lung cancer patients underwent surgical resection. We will use part of this cohort to built the predictive models and a second part to validate the creted models.

Procedure: surgical resection

Interventions

surgical resectionPROCEDURE

surgical resection of the lung cancer

enrolled patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients affected by early stage Non small cell lung cancer underwent surgical resection.

You may qualify if:

  • Patients with (suspected) NSCLC
  • Age \>18 yrs
  • ECOG 0-3
  • Written Informed Consent

You may not qualify if:

  • ECOG 4
  • Psychosocial, or emotional conditions controindicating participation to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lococo F, Boldrini L, Diepriye CD, Evangelista J, Nero C, Flamini S, Minucci A, De Paolis E, Vita E, Cesario A, Annunziata S, Calcagni ML, Chiappetta M, Cancellieri A, Larici AR, Cicchetti G, Troost EGC, Adany R, Farre N, Ozturk E, Van Doorne D, Leoncini F, Urbani A, Trisolini R, Bria E, Giordano A, Rindi G, Sala E, Tortora G, Valentini V, Boccia S, Margaritora S, Scambia G. Lung cancer multi-omics digital human avatars for integrating precision medicine into clinical practice: the LANTERN study. BMC Cancer. 2023 Jun 13;23(1):540. doi: 10.1186/s12885-023-10997-x.

    PMID: 37312079DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Non small cell lung cancer specimen surgically resected

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

sara flamini

CONTACT

3457235931sarafla@hotmail.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

April 7, 2023

Study Start

June 1, 2023

Primary Completion

October 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

April 7, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share