Lung Cancer Clinical Trial
Official title:
Molecular Profiling and Dynamic Changes of Circulating Tumor DNA in Unresectable Locally Advanced Non-small Cell Lung Cancer
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Parc de Salut Mar - Hospital del Mar | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar | GUARDANT HEALTH |
Spain,
Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantitative variation of aberrant methylated ctDNA concentrations before chemoradiotherapy, after chemoradiotherapy, and every 3 months during 1 year of follow-up. | 16 months | ||
Primary | Correlation between patients' recurrence or progression, and quantitative detection of circulating tumour DNA (ctDNA) concentration. | 2 years | ||
Primary | Concordance of ctDNA genomic alterations detected in peripheral blood samples, with those in matched tumour samples. | At diagnosis | ||
Primary | Correlation between survival outcomes (progression free survival, overall survival) and quantitative detection of ctDNA genomic alterations or methylation status. | 2 years |
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