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Идёт набор NCT05564026

Molecular Epidemiology of Pediatric Germ Cell Tumors

— Наблюдательное Germ Cell Tumor Germinoma Teratoma Embryonal 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: Questionnaire Administration, Tumor Specimen Collection, Germline DNA Samples, Blood Sample Collection.
Кому может быть актуально
Состояния в реестре: Germ Cell Tumor, Germinoma, Teratoma, Embryonal Carcinoma. 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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Официальное название

Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics

Обзор

A Non-Therapeutic Study that aims to establish a cohort of GCT survivors to understand short term and long-term adverse effects of treatment and to conduct molecular analyses to improve risk stratification.

Подробное описание

PRIMARY OBJECTIVES:

I. Establish a survivorship cohort for pediatric and adolescent GCT comprised of participants from AEPI10N1 and APEC14B1 to assess short term and long-term adverse events associated with GCT treatment.

II. Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification.

III. Identify methylation patterns that predict poor clinical outcomes, including disease relapse and death.

OUTLINE:

Medical records from pediatric and adolescent Germ Cell Tumor (GCT) participants from AEPI10N1 and APEC14B1 will be used to obtain treatment information and validate self-reported outcomes. Paired normal and tumor samples will be used to evaluate single nucleotide variants, indels, copy number variations, and DNA methylation patterns. Ototoxicity will be determined by central review of audiogram files obtained from the treating institutions and self-reported based on questionnaire data.

Вмешательства

  • Другое Questionnaire Administration
    Questionnaire provide to participant's about their health and quality of life since treatment
  • Другое Tumor Specimen Collection
    Tumor DNA requested from the Biopathology Center
  • Другое Germline DNA Samples
    Germline DNA specimens requested from the Biopathology Center or newly collected saliva
  • Процедура Blood Sample Collection
    Collection and storing of serum/plasma

Первичные конечные точки

  • Ototoxicity [Срок оценки: Up to 5 years]
  • Somatic Mutations [Срок оценки: Up to 5 years]
  • Methylation [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

  • Cases will be eligible for the study if they have a primary diagnosis of GCT including germinoma (ICCC code105 9060-9065), teratoma (9080-9084), embryonal carcinoma (9070-9072), yolk sac tumor (9071), choriocarcinoma (9100, 9103, 9104), and mixed GCT (9085, 9101, 9102, 9105) in all sites including the brain.
  • The patient must be enrolled on APEC14B1 with consent to future contact or enrolled in AEPI10N1 with consent for future contact (N=827). Patients enrolled in AEPI10N1 were recruited from ACCRN07. All patients must be registered with COG by a North American member institution. Note: (history of) treatment on a COG therapeutic trial is not required.
  • Patients must be diagnosed at < 20 years of age at the time of GCT diagnosis. Study participants will be followed over time in the survivorship study so there is no maximum age for participation.
  • Participants must be able to complete study related documents in English or Spanish.
  • All patients and/or their parents or legal guardians must provide informed consent. Assent will be obtained for participants between the ages of 8-17 years.
  • All institutional, FDA, and NCI requirements for human studies must be met.

Критерии исключения

  • Participants from AEPI10N1 who did not consent to future contact. Patients who do not meet the eligibility criteria described above or cannot complete study materials in English or Spanish

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

Дизайн исследования

Модель наблюдения
Семейное

Центры проведения

США · 1 центр
  • University of Minnesota — Minneapolis

Идентификаторы

NCT: NCT05564026 · AEPI17N3

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗