Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC

Recruiting

• Conditions: Unresectable Lung Carcinoma; Lung Cancer; Stage III Lung Cancer

• Registration Number: NCT05641870
• Lead Sponsor: Parc de Salut Mar

Brief Summary

Multi-center observational clinical study to evaluate the application value of ctDNA monitoring in efficacy assessment and relapse prediction in patients diagnosed with unresectable, locally advanced NSCLC receiving CRT with or without durvalumab maintenance treatment.

Detailed Description

Newly diagnosed, histologically confirmed, unresectable stage III NSCLC patients, amenable to receive standard of care chemoradiotherapy with or without durvalumab maintenance, will be enrolled in this study. Whole blood collection will be conducted during the treatment for ctDNA detection in specific time-points of interest. Next-generation sequencing using commercially available panels, and analysis of ctDNA aberrant methylation will be performed. Results will be correlated to patients' recurrence times and survival outcomes.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-11-29
• Status Verified: 2022-12
• Study First Posted: 2022-12-08
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-12
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients with newly diagnosed, histologically confirmed, unresectable locally advanced NSCLC.
• ≥18 years of age.
• Ability to understand the written informed consent and willingness to sign it.

Exclusion Criteria

• Patients who are unwilling to follow-up evaluation of response to therapy.
• Any condition that, in the opinion of the investigator, would interfere with study results.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance of ctDNA genomic alterations detected in peripheral blood samples, with those in matched tumour samples.	At diagnosis
Correlation between survival outcomes (progression free survival, overall survival) and quantitative detection of ctDNA genomic alterations or methylation status.	2 years
Quantitative variation of aberrant methylated ctDNA concentrations before chemoradiotherapy, after chemoradiotherapy, and every 3 months during 1 year of follow-up.	16 months
Correlation between patients' recurrence or progression, and quantitative detection of circulating tumour DNA (ctDNA) concentration.	2 years

Trial Locations

Locations (1)

Parc de Salut Mar - Hospital del Mar; 🇪🇸 Barcelona, Spain