Идёт набор NCT06807307

Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential

— Наблюдательное NSCLC

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: NSCLC. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

KEAPnes: Transcriptional Framework for the Molecular Diagnosis of Response to Immunotherapy in Lung Cancer With Agnostic Potential

Обзор

Through genomic and transcriptomic sequencing techniques (whole exome sequencing, WES; whole transcriptome sequencing, WTS) patients with enrichment for KEAPness and specific gene interactions associated with it.

Подробное описание

Retrospective-prospective, non-pharmacological, biological, multicenter observational study, for which the collection and use of tissue samples from patients suffering from NSCLC and/or other tumor types. Through genomic and transcriptomic sequencing techniques (whole exome sequencing, WES; whole transcriptome sequencing, WTS) patients with enrichment for KEAPness and specific gene interactions associated with it. Subsequently, through the same techniques, applied to different tumor regions taken from operating site it will be possible to identify the evolution of the tumor at a spatio-temporal level and the immune subtype associated with the presence/absence of KEAPness. Finally, cell lines will be used to recapitulate what was observed in the patient and per-patient cohorts identify new pharmacological vulnerabilities associated with the characteristics of KEAPness.

Первичные конечные точки

Innovative molecular tool [Срок оценки: 24 months]

Вторичные конечные точки (2)

Tracing the evolutionary path [Срок оценки: 24 months]
Identification of therapeutic vulnerabilities specific [Срок оценки: 24 months]

Критерии участия

Inclusion Criteria cohort (NSCLC-IC):

Age >18 years;
Histological diagnosis of NSCLC
metastatic disease
Availability, at the time of enrollment, of adequate biological material to be able to perform molecular analyses, taken (surgical or by biopsy) before administration of any anti-tumor treatment (chemotherapy and/or radiotherapy);
ECOG PS 0-2;
Adequate hematological, hepatic and renal function;
Measurable disease according to RECIST criteria
Availability of follow-up data for at least 6 months and/or until death/progression

Exclusion Criteria cohort (NSCLC-IC):

Previous systemic therapy for metastatic disease;
Comorbidities not controlled with adequate medical therapy.

Inclusion Criteria NSCLC-VC cohort:

Age >18 years;
Histological diagnosis of NSCLC
metastatic disease
Availability, at the time of enrollment, of adequate biological material to be able to perform molecular analyses, taken (during surgery and/or by biopsy) before administration of any anti-tumor treatment (chemotherapy and/or radiotherapy);
ECOG PS 0-2;
Adequate hematological, hepatic and renal function;
Measurable disease according to RECIST criteria;
Written informed consent (participation in the study and data processing)

Exclusion Criteria NSCLC-VC cohort: