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Идёт набор NCT06695494

Enabling Genomic Testing in Cancer of Unknown Primary

— Наблюдательное Cancer of Unknown Primary Neoplasm, Unknown Primary

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
В протоколе указаны: Gene panel array, Blood Sample Collection.
Кому может быть актуально
Состояния в реестре: Cancer of Unknown Primary, Neoplasm, Unknown Primary. Базовые параметры: от 16 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
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Cancer of Unknown Primary (CUP) is where cancer cells are found in the body but the place the cancer began is not known. It is the 6th leading cause of cancer death in the UK and the prognosis is poor with a median survival of 6-9 months. There is a higher than average incidence of CUP in the North West (NW) of England (population of 7.4 million). Precision medicine has transformed treatment strategies in known tumour types, however in CUP there remains an urgent need to better understand CUP molecular characteristics to establish potential roles for novel therapeutic strategies. Treatment options remain limited due to difficulties in determining the primary site of the tumour and the lack of access to validated biomarkers. Access to good-quality tissue for molecular profiling remains a huge challenge in CUP. The emergence of liquid biopsies (sequence DNA in a blood test) as a source of biomarkers is also gaining rapid ground and this study aims to explore the potential utility of liquid biopsies in CUP.

Вмешательства

  • Диагностический тест Gene panel array
    Blood sample collection for gene panel testing
  • Другое Blood Sample Collection
    Blood sample collection for research purposes

Первичные конечные точки

  • Evaluate the utility of cfDNA molecular profiling in patients diagnosed with CUP [Срок оценки: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first]
Вторичные конечные точки (3)
  • Data collection repository of readily available information on trails/treatments for patients diagnosed with CUP [Срок оценки: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first]
  • Incorporate molecular genomics into routine practice [Срок оценки: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first]
  • Document and feedback genomic results to treating team and patients [Срок оценки: 33 months of recruitment + 12 months follow up period or 1 December 2027 whichever comes first]

Критерии участия

Критерии включения

  • Aged 16 years or over
  • Written informed consent according to ICH/GCP and national regulations
  • ECOG Performance status 0-2
  • Confirmed diagnosis of CUP as per the ESMO guidelines. Patients must have;
  • The local pathology reports confirming compatibility with CUP diagnosis and the associated slides used for the diagnosis
  • Discussion at a local CUP MDT confirming diagnosis
  • Availability of archival tumour histological report
  • Willingness to provide blood samples on up to two occasions during the study

Критерии исключения

  • Patient with an immunohistochemistry profile that provides a definitive clinical indication of a primary cancer with a specific treatment
  • Known HIV, Hepatitis B, C positive, due to the difficulties in handling high-risk specimens
  • Patients who are unable to provide fully informed written consent
  • Presence of any medical, psychological, familial or sociological condition that, in the investigator's opinion, will hamper compliance with the study protocol and follow-up schedule
  • Bleeding diathesis (patients' on anticoagulation are permitted to enter the trial if anticoagulation can be safely managed to enable blood sampling)
  • Conditions in which blood sampling may increase risk of complications for the patients and/or investigator

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 6 центров
  • The Christie NHS Foundation Trust — Manchester
  • The Clatterbridge Cancer Centre NHS Foundation Trust — Liverpool
  • Blackpool Teaching Hospitals NHS Foundation Trust — Blackpool
  • Northern Care Alliance NHS Foundation Trust — Manchester
  • University Hospitals of Morecambe Bay NHS Trust — Morecambe
  • Lancashire Teaching Hospitals NHS Foundation Trust — Preston

Идентификаторы

NCT: NCT06695494 · CFTSp213 · ISRCTN42910771

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗