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Идёт набор NCT04510129

A Multicenter Cancer Biospecimen Collection Study

— Наблюдательное Cancer of Head and Neck Lung Cancer, Nonsmall Cell Small-cell Lung Cancer Urothelial Carcinoma

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: OncoPrism™ assay.
Кому может быть актуально
Состояния в реестре: Cancer of Head and Neck, Lung Cancer, Nonsmall Cell, Small-cell Lung Cancer, Urothelial Carcinoma. 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
США
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

Predicting Immunotherapy Efficacy from Analysis of Pre-treatment Tumor Biopsies

Обзор

This study will collect de-identified tumor samples, with correlated clinical/demographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor biopsy. These specimens and clinical data may be used in subsequent studies for the development and validation of a diagnostic test.

Подробное описание

This study will establish a prospective cohort of pre-treatment tumor specimens with correlated de-identified clinical and demographic data and tissue histology from cancer patients who are undergoing treatment with PD-1/PD-L1 inhibitors. Patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1/PD-L1 treatment will be enrolled.

The study will not require a study-specific tumor biopsy; any biopsies taken prior to treatment as part of standard of care are eligible for this study. Biopsies must not have been taken after immunotherapy treatment began.

Participants will be asked to provide their consent for the potential use of their biospecimens in subsequent studies for the development and validation of a diagnostic test.

Вмешательства

  • Диагностический тест OncoPrism™ assay
    OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.

Первичные конечные точки

  • PD-L1/PD-1 inhibitor response [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Subject must have a disease of interest. Specifically, subject must have one of:
  • head and neck squamous cell carcinoma (HNSCC)
  • non-small-cell lung cancer (NSCLC)
  • small cell lung cancer (SCLC)
  • urothelial carcinoma (UCC)
  • gastric or gastroesophageal junction adenocarcinoma
  • cervical cancer
  • esophageal squamous cell carcinoma (ESCC)
  • triple-negative breast cancer (TNBC)
  • hepatocellular carcinoma (HCC)
  • renal cell carcinoma (RCC)
  • colorectal cancer (CRC)
  • Subject must have received, or be scheduled to receive, at least one dose of anti-PD-1/PD-L1 immunotherapy for treatment of their cancer.
  • Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
  • Subject must have undergone, or will undergo, medical imaging (e.g. CT or MRI) of the tumor prior to treatment with anti-PD-1/PD-L1 immunotherapy.
  • Willing to provide electronic informed consent per IRB-approved protocol.
  • Able to speak, read, and comprehend English fluently.
  • Subject is 18 years of age or older.
  • Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.

Критерии исключения

  • Inability or unwillingness to provide informed consent.
  • Subject who does/did not have one of the cancers listed above (other histologies).
  • Subject has already participated in this trial.

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

США · 1 центр
  • Curebase — San Francisco

Публикации

  • Flanagan KC, Earls J, Hiken J, Wellinghoff RL, Ponder MM, McLeod HL, Westra WH, Vavinskaya V, Sutton L, Deichaite I, Macdonald OK, Welaya K, Wade J 3rd, Azzi G, Pippas AW, Slim J, Bank B, Sui X, Kossman SE, Shenkenberg TD, Alexander WL, Price KA, Ley J, Messina DN, Glasscock JI, Colevas AD, Cohen EEW, Adkins D, Duncavage EJ. Multicenter validation of an RNA-based assay to predict anti-PD-1 disease PMID 39489541

Идентификаторы

NCT: NCT04510129 · PREDAPT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗