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Идёт набор NCT06028724

A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)

— Наблюдательное Solid Tumor Advanced Solid Tumor Locally Advanced Solid Tumor Colon Rectal Cancer

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: Solid Tumor, Advanced Solid Tumor, Locally Advanced Solid Tumor, Colon Rectal Cancer. 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

A Prospective, Observational Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)

Обзор

The implementation of liquid biopsy in clinical practice has been favored by the rapid development of genome sequencing techniques designed to analyze mutations in ctDNA. Among these, the Next generation sequencing (NGS) is a technique that consists in sequencing several genomes in a short time span, collecting information about a wider range of genomic alterations, using small quantities of genetic material. It is used to identify potential circulating dynamic biomarkers of treatment sensitivity or resistance in a real word multi-pathology evaluation. In this way, defining the mutational status of clinical relevance genes in real world, as a predictive biomarker to identify those patients most likely to benefit from target therapy, offers the potential to optimize access to further therapies. The aim of this study is to evaluate the real-world prevalence of clinically useful mutations in patients who are receiving therapy for advanced and locally advanced solid tumor through liquid biopsy.

Первичные конечные точки

  • Real world prevalence of clinically useful mutations in solid tumors [Срок оценки: at the beginning of treatment]
Вторичные конечные точки (6)
  • To identify emerging gene alterations associated with Progression Free Survival [Срок оценки: from study enrollment until progression or death for any cause, up to 7 years]
  • To identify emerging gene alterations associated with Overall Survival [Срок оценки: from study enrollment until death for any cause, up to 7 years]
  • To describe changes in ctDNA associated biomarkers during treatment [Срок оценки: up to 7 years]
  • To evaluate the association between somatic genetic alterations and the histopathological features of the tumor [Срок оценки: up to 7 years]
  • To evaluate the association between somatic genetic alterations and pattern of metastasis [Срок оценки: up to 7 years]
  • To evaluate the association between somatic genetic alterations and the clinical characteristic of the enrolled patients [Срок оценки: up to 7 years]

Критерии участия

Критерии включения

Patients eligible for inclusion in this study have to meet all of the following criteria:

  • Patients, 18 years of age or older
  • Competent and able to comprehend, sign and date an Ethics Committee (EC) approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  • Histologically proven diagnosis solid tumor
  • Diagnosis of advanced or locally advanced disease
  • Patients candidated to receive standard therapy in the following line:
  • first, second or third-line therapy for colon-rectal cancer in IV stage
  • first or second-line therapy for gastric cancer in IV stage
  • primary intent or first-line therapy for pancreatic cancer
  • first-line therapy for bile duct cancer
  • first or second-line therapy for hepatocarcinoma
  • first, second, third, fourth or fifth-line therapy for breast cancer in IV stage
  • chemotherapy for ovarian cancer in advanced stage (FIGO III-IV) and at the time of first relapse
  • first or second-line therapy for endometrial cancer in advanced stage (FIGO III-IV)
  • first or second-line therapy for advanced or locally advanced cervical cancer
  • therapy for locally advanced or first line therapy for metastatic vulva cancer
  • first, second or third-line therapy for melanoma (third-line therapy only in BRAF-mutated melanoma)

Критерии исключения

  • Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
  • Patients unable or unwilling to undergo as per protocol assessments at the four planned timepoints

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano — Aviano

Идентификаторы

NCT: NCT06028724 · CRO-2022-51

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗