Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC
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|ClinicalTrials.gov Identifier: NCT05641870|
Recruitment Status : Recruiting
First Posted : December 8, 2022
Last Update Posted : December 12, 2022
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|Condition or disease||Intervention/treatment|
|Lung Cancer Stage III Lung Cancer Unresectable Lung Carcinoma||Procedure: Sample collection Diagnostic Test: Characterization of the tumoral tissue genomic alterations Drug: Chemoradiation treatment regimen and maintenance (if amenable) Diagnostic Test: Genomic and methylation analysis in liquid biopsy|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||80 participants|
|Target Follow-Up Duration:||16 Months|
|Official Title:||Molecular Profiling and Dynamic Changes of Circulating Tumor DNA in Unresectable Locally Advanced Non-small Cell Lung Cancer|
|Actual Study Start Date :||February 1, 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
- Procedure: 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.
- Diagnostic Test: 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.
- Drug: 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.
- Diagnostic Test: 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.
- Quantitative variation of aberrant methylated ctDNA concentrations before chemoradiotherapy, after chemoradiotherapy, and every 3 months during 1 year of follow-up. [ Time Frame: 16 months ]
- Correlation between patients' recurrence or progression, and quantitative detection of circulating tumour DNA (ctDNA) concentration. [ Time Frame: 2 years ]
- Concordance of ctDNA genomic alterations detected in peripheral blood samples, with those in matched tumour samples. [ Time Frame: At diagnosis ]
- Correlation between survival outcomes (progression free survival, overall survival) and quantitative detection of ctDNA genomic alterations or methylation status. [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Newly diagnosed, histologically confirmed, unresectable stage III NSCLC patients, amenable to receive standard of care chemoradiotherapy with or without durvalumab maintenance.
Patients will be recruited in two centers: Hospital del Mar (Barcelona, Spain) and Instituto Português de Oncologia (Porto, Portugal). The expected number of enrolments is 30-40 patients per year per institution. All patients will be informed of the research nature of the study and will be included after written informed consent is provided.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05641870
|Contact: Edurne Arriola||932483137 ext +firstname.lastname@example.org|
|Contact: Pedro Rochaemail@example.com|
|Parc de Salut Mar - Hospital del Mar||Recruiting|
|Barcelona, Spain, 08003|
|Contact: Edurne Arriola 932483137 firstname.lastname@example.org|
|Contact: Pedro Rocha 932483137 email@example.com|
|Principal Investigator:||Edurne Arriola||Parc de Salut Mar|
|Responsible Party:||Edurne Arriola, Principal Investigator, Parc de Salut Mar|
|Other Study ID Numbers:||
|First Posted:||December 8, 2022 Key Record Dates|
|Last Update Posted:||December 12, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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