Lung Cancer ID (Identity) Study

April 4, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Demographic, Clinical, Histological and Molecular Characteristics of Advanced LUNG CANCER at the tIme of Diagnosis in a Large Italian Cohort: an Observational Cohort Study: Lung Cancer ID Study

The distribution of demographic, clinical, radiological, pathological and molecular characteristics of lung cancer at the time of diagnosis, as well as preferential association between elements of those domains, have not been specifically studied in Italy. The aim of the present project is to assess, in a systematic fashion, the demographic, clinical, radiological, pathological and molecular characteristics of advanced lung cancer at the time of diagnosis in a large Italian cohort of consecutive patients referred to two tertiary referral centers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Roma, Italy
        • Not yet recruiting
        • Istituto Nazionale Tumori Regina Elena
        • Contact:
          • Federico Cappuzzo, MD
      • Roma, Italy
      • Roma, Italy
        • Not yet recruiting
        • Medical Oncology Division - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
          • Emilio Bria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Consecutive, treatment-naïve, patients with clinical and radiological suspicion of advanced lung cancer referred for the initial diagnosis/staging/molecular profiling.

Description

Inclusion Criteria:

  • Age >18 years
  • Suspicion of lung cancer based on imaging (CT and/or PET/CT)
  • Indication to a biopsy for diagnosis, staging and/or molecular profiling

Exclusion Criteria:

  • Inability or unwillingness to provide a written informed consent
  • ECOG performance status (>3) which makes a tissue diagnosis unfeasible
  • ASA 4 status
  • TNM Stage I-III

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of histologic subtypes
Time Frame: 24 months
The investigators will assess the prevalence of histologic subtypes in patients with advanced lung cancer
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular profiling
Time Frame: 24 months
Prevalence of individual molecular markers in patients with advanced non-squamous non-small cell lung cancer histology
24 months
Time to diagnosis
Time Frame: 24 months
Time lag between onset of symptoms (if any) and invasive testing
24 months
Distribution of histologic subtypes according to clinical and radiological characteristics
Time Frame: 24 months
The investigators will assess the prevalence of different histologic subtypes according to clinical and imaging characteristics
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5937

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators will decide how to share the data at the end of the study upon reasonable request to be addressed to the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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