Impact of ctDNA in Cancer Early Detection and STAS Evaluation in Patients With GGOs

Impact of Circulating Tumor DNA on Early Cancer Detection and Evaluation of STAS in Patients With Ground Glass Opacities

The aim of the study is the early and non-invasive diagnosis of lung cancer in patients with pulmonary ground glass opacity. In particular, objective of the study is to evaluate the presence or absence of circulating tumor DNA (ctDNA) on the peripheral blood of patients with evidence of ground glass opacity(GGO) at CT scan and to evaluate the role that this can play in the diagnostic / therapeutic process. The ctDNA evaluation will be performed at the first radiological finding and subsequently correlated with the malignancy of the lesion based on the radiological / histological criteria regularly used in international protocols.

Secondary objective is the correlation, in patients with malignant GGO undergoing surgical treatment, of the ctDNA presence and tumor spread through the air spaces (STAS), and its correlation with local relapses.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Circulating Tumor Cell; Spreading of Tumor
• Intervention / Treatment: Diagnostic test: cf DNA and ct DNA

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Marco Anile, MD; Phone Number: +390649970220; Email: marco.anile@uniroma1.it

Study Locations

• Italy
  • Roma, Italy
    • Recruiting
    • Thoracic Surgery Unit, Sapienza University of Rome
    • Contact: Marco Anile, MD; Phone Number: +390649970220; Email: marco.anile@uniroma1.it
    • Contact: Massimiliano Bassi, MD; Phone Number: +390649970220; Email: massimiliano.bassi@uniroma1.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with radiological finding of pulmonary ground glass opacity of unknown origin

Description

Inclusion Criteria:

• age> 18 years
• radiological finding of pulmonary ground glass opacity
• absence of solid or haematological tumor

Exclusion Criteria:

• radio / chemotherapy treatment for at least 6 months
• patient unable to understand and express his consent to the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Malignant GGOs; Patients with histologically proven malignant pulmonary ground glass opacities (GGOs)	Diagnostic test: cf DNA and ct DNA; Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA
Benign GGOs; Patients with histologically or radiologically proven benign pulmonary ground glass opacities (GGOs)	Diagnostic test: cf DNA and ct DNA; Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of cf DNA	Assess quantity of the circulating free DNA measured in ng/μL using Qubit 2.0	through study completion, an average of 2 year
Presence of ct DNA	Number of participants with of circulating tumor DNA using a lung pannel for genes: EGFR, KRAS, NRAS, TP53, SKT11, DDR2, PIK3CA, FGFR3, CTNNB1, MET, BRAF, ERBB2, SMAD4, PTEN, AKT, FGFR2, ERBB4, NOTCH1, FGFR1, ALK, IDH1, HRAS, IDH2, PDGFRA, RET, ROS1	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Investigators: Principal Investigator: Marco Anile, MD, University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: December 24, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasm Metastasis; Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: GGO ctDNA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No