NCT06331975

Brief Summary

In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 12, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

4.6 years

First QC Date

March 18, 2024

Last Update Submit

March 18, 2024

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

  • Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status

    The status of EGFR, ALK, KRAS will be validated for its association with nodal status at surgery

    1 month

  • Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS)

    Number of patiens with EGFR, ALK, KRAS mutations alive at five years

    5 years

  • Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS)

    Number of patiens with EGFR, ALK, KRAS mutations with an oncological event (local or distant) during follow up

    5 years

Study Arms (1)

Radiomic signature

OTHER

Assessment of radiomic signature and tumor genetic profile at baseline

Diagnostic Test: Radiomic signature

Interventions

Radiomic signatureDIAGNOSTIC_TEST

Assessment of radiomic signature and tumor genetic profile in patients with Non Small Cell Lung Cancer (NSCLC)

Radiomic signature

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with diagnosis of NSCLC
  • patients candidates for mutational status assessment

You may not qualify if:

  • \- patients with age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, Italy

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

  • Francesca Botta

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 26, 2024

Study Start

June 12, 2018

Primary Completion

January 31, 2023

Study Completion

September 14, 2023

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations

IT(1)