Tumor Associated Neutrophils as a Biomarker of Chemo-immunotherapy Response in Locally Advanced Non-small Cell Lung Cancer : a Model Based on Neoadjuvant Strategy

Обзор

evaluate the predictive value of circulating neutrophil DNA methylation profiles, identified from the ALCINA 2 cohort, on pre-treatment blood samples (T0), for the histological response to neoadjuvant chemo-immunotherapy in patients with resectable non-small cell lung cancer (NSCLC)

Вмешательства

• Другое blood sampling
  blood sampling

Первичные конечные точки

• Area under the ROC curve (AUC) of neutrophil DNA methylation profiles for predicting histologic response [Срок оценки: 6 Months after inclusion]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Resectable non-small cell lung cancer (NSCLC), stage IIA to IIIB.
• Lymph node status obtained by Positron Emission Tomoscintigraphy (PET)-scanner, confirmation of lymph node status by optional histological sampling (mediastinoscopy, thoracoscopy, echo-endoscopy).
• No secondary lesions in the cerebrum or extra-cerebrum confirmed on brain MRI, PET scanner +/- injected cerebro-thoraco-abdomino-pelvic scanner.
• Neoadjuvant immunochemotherapy strategy validated by a multidisciplinary consultation meeting (RCP) prior to the start of treatment.
• Lung function compatible with thoracic surgery, patient meets surgical and anesthetic criteria for operability
• Measurable disease according to RECIST criteria version 1.1

Критерии исключения

• Previous systemic treatment for the same CBNPC.
• Diagnosis of another solid tumor within the last 3 years, ‡ excluding non melanoma cutaneous and cervical carcinomas .
• Contraindication to immunotherapy.
• Non-objection to participate in research not collected.
• Patients unable to read and/or write.
• Inability to monitor patient during study period
• Persons unable to express their consent.
• Not affiliated to a social security scheme.
• Persons under court protection.
• Persons participating in another research study with an ongoing exclusion period.
• Pregnant women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 1 центр

• CHU de Montpellier - Hôpital Arnaud de Villeneuve — Montpellier

Публикации

• Mistry P, Nakabo S, O'Neil L, Goel RR, Jiang K, Carmona-Rivera C, Gupta S, Chan DW, Carlucci PM, Wang X, Naz F, Manna Z, Dey A, Mehta NN, Hasni S, Dell'Orso S, Gutierrez-Cruz G, Sun HW, Kaplan MJ. Transcriptomic, epigenetic, and functional analyses implicate neutrophil diversity in the pathogenesis of systemic lupus erythematosus. Proc Natl Acad Sci U S A. 2019 Dec 10;116(50):25222-25228. doi: 10. PMID 31754025
• Engblom C, Pfirschke C, Zilionis R, Da Silva Martins J, Bos SA, Courties G, Rickelt S, Severe N, Baryawno N, Faget J, Savova V, Zemmour D, Kline J, Siwicki M, Garris C, Pucci F, Liao HW, Lin YJ, Newton A, Yaghi OK, Iwamoto Y, Tricot B, Wojtkiewicz GR, Nahrendorf M, Cortez-Retamozo V, Meylan E, Hynes RO, Demay M, Klein A, Bredella MA, Scadden DT, Weissleder R, Pittet MJ. Osteoblasts remotely supply PMID 29191879
• Akbay EA, Koyama S, Liu Y, Dries R, Bufe LE, Silkes M, Alam MM, Magee DM, Jones R, Jinushi M, Kulkarni M, Carretero J, Wang X, Warner-Hatten T, Cavanaugh JD, Osa A, Kumanogoh A, Freeman GJ, Awad MM, Christiani DC, Bueno R, Hammerman PS, Dranoff G, Wong KK. Interleukin-17A Promotes Lung Tumor Progression through Neutrophil Attraction to Tumor Sites and Mediating Resistance to PD-1 Blockade. J Thora PMID 28483607

Идентификаторы

NCT: NCT06974097 · RECHMPL24_0275

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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