Lung Cancer ID (Identity) Study

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06076005
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 500
• Patients Per Site Per Month: 20.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Stage IV	Other: Advanced lung cancer patients' group

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2025
• Anticipated Study Completion Date: Oct 31, 2025

Outcome Measures

Primary Outcome Measures

1. Distribution of histologic subtypes [24 months]

   We will assess the prevalence of histologic subtypes in patients with advanced lung cancer

Secondary Outcome Measures

1. Distribution of histologic subtypes according to clinical and radiological characteristics [24 months]

   We will assess the prevalence of different histologic subtypes according to clinical and imaging characteristics

2. Molecular profiling [24 months]

   Prevalence of individual molecular markers in patients with advanced non-squamous non-small cell lung cancer histology

3. Time to diagnosis [24 months]

   Time lag between onset of symptoms (if any) and invasive testing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma		Italy
2	Istituto Nazionale Tumori Regina Elena	Roma		Italy

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT06076005
• Other Study ID Numbers: 5937
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Oct 10, 2023