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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05187767
• Other study ID #: GGO ctDNA
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: November 2022
• Source: University of Roma La Sapienza
• Contact: Marco Anile, MD
• Phone: +390649970220
• Email: marco.anile[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Lung Cancer
• Neoplasms
• Neoplastic Cells, Circulating

Intervention

Diagnostic Test:
• cf DNA and ct DNA
Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA

Locations

Country	Name	City	State
Italy	Thoracic Surgery Unit, Sapienza University of Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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