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Идёт набор NCT04852354

Tissue Collection for Drug Screening and Bioanalysis

— Наблюдательное Central Nervous System Tumor

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: Central Nervous System Tumor. Базовые параметры: Без ограничений · 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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Обзор

The purpose of this study is to improve upon the knowledge currently available about central nervous system (CNS) tumors. We will study the different characteristics of these tumors using tissue samples collected during surgery and post-autopsy. The aim is to create tumor cell lines and models to test how they respond to different drugs. This research will help improve treatment options and identify new targets for therapy.

Подробное описание

The goal of this project is to enable the acquisition of tissue available for research with the prospect of enabling the development of new therapeutic avenues for patients diagnosed with cancer in the central nervous system.

During patients' (with a CNS tumor) routine operative procedure, if extra tissue deemed unnecessary for diagnostic or clinical purposes is available, selected samples will undergo DNA and/or RNA extraction and integrity analysis, whole genome and RNA sequencing, DNA and RNA methylome analyses, proteomic analysis, immunoprofiling, and primary culturing of the tumor cells. These cultures may then be used for drug screenings and to create patient-derived xenografts, or for comparisons between tumor and non-tumor patients. Other biological samples may be collected. Tissue collection for drug screening will be extended to post-mortem biospecimens such as whole brain, spinal cord, biofluids (e.g., cerebrospinal fluid and blood) and skin biopsy. These samples will be collected through autopsy donation from pediatric and adult brain tumor patients.

Additionally, saliva samples may be obtained from the parents of pediatric patients with CNS tumors, and biological samples may be collected from pediatric patients without a CNS tumor who are undergoing a neurological procedure. These samples may be used for comparison with samples from patients with CNS tumors.

Первичные конечные точки

  • Evaluating and characterizing the genetic, immunohistochemical, cellular, and molecular profiles of pediatric neoplastic lesions [Срок оценки: Through study completion, average 1-3 years]

Критерии участия

Inclusion Criteria for Tumor patients undergoing neurosurgery (cohort 1)

  • Subject has presented with a suspected/confirmed neoplastic CNS lesion and is undergoing a neurosurgical procedure in which CNS tissue and/or tumors associated with this tissue will be removed.
  • There must be tissue available in excess of that required by neuropathology for diagnostic purposes.
  • Subject of all ages included.
  • Subjects who are pregnant can be included.
  • Subjects who are neonates (0-4 weeks) can be included.

Inclusion Criteria for Non-tumor patients undergoing neurosurgery (cohort 2)

  • Subject is between 4 weeks and 21 years of age and is undergoing a neurosurgical procedure at WCMC.
  • Subject does not have a CNS tumor diagnosis.
  • Subject should not be pregnant at the time of enrollment.

Inclusion Criteria for Autopsy tumor tissue donation (cohort 3)

  • Subject of all ages included
  • Subject has been diagnosed with a neoplastic CNS lesion at the time of passing.
  • Subjects who are pregnant can be included.
  • Subjects who are neonates (0-4 weeks) can be included.

Inclusion Criteria for parent of tumor patients

  • Subject is the biological parent of a patient undergoing/ who underwent a neurosurgical procedure in which CNS tissue and/or tumors associated with this tissue will be/ was removed.
  • Subject is the biological parent of patient enrolled in cohort 1.
  • Subject is not pregnant at the time of enrollment.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 1 центр
  • Weill Cornell Medicine — New York

Публикации

  • Rajappa P, Cobb WS, Vartanian E, Huang Y, Daly L, Hoffman C, Zhang J, Shen B, Yanowitch R, Garg K, Cisse B, Haddock S, Huse J, Pisapia DJ, Chan TA, Lyden DC, Bromberg JF, Greenfield JP. Malignant Astrocytic Tumor Progression Potentiated by JAK-mediated Recruitment of Myeloid Cells. Clin Cancer Res. 2017 Jun 15;23(12):3109-3119. doi: 10.1158/1078-0432.CCR-16-1508. Epub 2016 Dec 30. PMID 28039266

Идентификаторы

NCT: NCT04852354 · 20-01021289

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗