Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC
NCT ID: NCT05641870
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2021-02-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Sample collection
Tumor samples will be collected as standard diagnostic procedure at diagnosis. Plasma samples from whole blood extractions will also be collected at diagnosis, after chemoradiotherapy, and every 3 months from there until completing one year of follow-up.
Characterization of the tumoral tissue genomic alterations
Genomic alterations of tumor tissue samples will be analyzed locally by next-generation sequencing when material is adequate, as standard diagnostic procedure.
Chemoradiation treatment regimen and maintenance (if amenable)
Patients will be treated with standard chemotherapy (following the clinical practice at each institution). Radiotherapy will be delivered concurrently when feasible with a total dose of 60-66 Gy. In selected cases, due to frailty of the patient or impaired pulmonary function, radiotherapy will be delivered sequentially. In tumors with positive PD-L1 expression, a year of durvalumab 10 mg/m2 every 2 weeks will be administered if there are no contraindications.
Genomic and methylation analysis in liquid biopsy
Blood samples for ctDNA genomic and methylation analysis (4 mL of plasma for each sample) will be sent to the Guardant Health Laboratories in the US and analyzed after Contractual Agreement signature, using the Guardant Reveal test.
This liquid biopsy test uses ctDNA to detect presence of MRD and monitor for recurrence after definitive surgical/systemic therapy for patients with cancer. It has been validated in early-stage colorectal cancer and integrates assessment of somatic alterations with an epigenomic cancer signature to identify the presence of methylation signatures associated with cancer versus normal DNA.
Eligibility Criteria
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Inclusion Criteria
* ≥18 years of age.
* Ability to understand the written informed consent and willingness to sign it.
Exclusion Criteria
* Any condition that, in the opinion of the investigator, would interfere with study results.
18 Years
ALL
No
Sponsors
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Guardant Health, Inc.
INDUSTRY
Parc de Salut Mar
OTHER
Responsible Party
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Edurne Arriola
Principal Investigator
Principal Investigators
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Edurne Arriola
Role: PRINCIPAL_INVESTIGATOR
Parc de Salut Mar
Locations
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Parc de Salut Mar - Hospital del Mar
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Edurne Arriola
Role: primary
Pedro Rocha
Role: backup
References
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Other Identifiers
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2022/10344/I
Identifier Type: -
Identifier Source: org_study_id