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Prospective Study on Resistance-associated Mutations in Metastatic Lung Cancer

NCT06081270 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2023-10-13

No results posted yet for this study

Summary

This single-centre prospective study is aimed at analysing, by means of liquid biopsy with next generation sequencing analysis on circulating tumor DNA, resistance mutations arising during therapy with selective inhibitors in patients with RTK-positive NSCLC or with mutations in the Ras/MAPK (mitogen-activated protein kinase) pathway, treated at the San Gerardo Hospital, Monza.

Conditions

Interventions

OTHER

Liquid biopsy

Blood withdrawal for each patient is performed (i) at the time of treatment initiation with tyrosine kinase inhibitors (TKI); (ii) at the time of the first planned instrumental re-evaluation according to clinical practice regardless of the type of response to the TKI employed (9-12 weeks); (iii) at the time of radiological progression according to RECIST 1 criteria. 1 at computerized tomography scan with contrast or metabolic progression at 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose during TKI therapy; (iv) at the time of the change of therapeutic strategy decided by the investigator when used beyond progression and not coinciding with point iii. The ctDNA is extracted from plasma and analyzed with Illumina sequencing method.

Sponsors & Collaborators

  • University of Milano Bicocca

    lead OTHER

Principal Investigators

  • Diego Cortinovis, MD · Fondazione IRCCS San Gerardo dei Tintori, Monza

  • Luca Mologni, PhD · University of Milano Bicocca

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-12
Primary Completion
2024-04-30
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06081270 on ClinicalTrials.gov