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Идёт набор NCT07378423

Questionnaire on Congenital Cancer Signs Through Self-Assessment

Без фазы С лечением Cancer Predisposition Syndromes Pediatric Cancer Childhood Neoplasms Hereditary Cancer Syndromes

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: Pre-Visit Preparation (PVP) Brochure, QUOCCAS Questionnaire, Germline genetic sequencing for Cancer Predisposition Syndromes (CPS), MIPOGG Assessment.
Кому может быть актуально
Состояния в реестре: Cancer Predisposition Syndromes, Pediatric Cancer, Childhood Neoplasms, Hereditary Cancer Syndromes. Базовые параметры: до 21 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
Швейцария
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

Questionnaire on Congenital Cancer Signs Through Self-Assessment (QUOCCAS)

Обзор

This clinical trial tests whether a patient- and caregiver-completed questionnaire (QUOCCAS) can accurately help identify children and adolescents with cancer who may have an underlying cancer predisposition syndrome (CPS). The study will also evaluate whether providing families with an educational brochure before their clinic visit improves their understanding of genetics and their satisfaction with care. The main questions it aims to answer are: * Does QUOCCAS identify children at risk for CPS as accurately as physician-based tools and compared to genetic testing? * Does the Pre-Visit Preparation (PVP) brochure improve caregiver knowledge about genetics? * Does the PVP brochure improve caregiver satisfaction with the care and information they receive? Participants will: * Complete the QUOCCAS questionnaire about family history, clinical features, and cancer signs * Provide a blood or saliva sample for genetic testing (whole-exome or whole-genome sequencing) * Randomly receive or not receive the educational Pre-Visit Preparation brochure before completing the questionnaire * Complete brief surveys on their knowledge and satisfaction

Вмешательства

  • Поведенческое Pre-Visit Preparation (PVP) Brochure
    Participants receive a Pre-Visit Preparation (PVP) brochure containing information about cancer predisposition syndromes, genetic testing, and implications for care. The brochure is provided before completion of the QUOCCAS questionnaire and is designed to improve caregiver knowledge, engagement, and satisfaction with care.
  • Диагностический тест QUOCCAS Questionnaire
    Participants complete the QUOCCAS questionnaire, a structured, self- or caregiver-reported tool designed to identify clinical features, family history, and signs suggestive of cancer predisposition syndromes. Responses are used to classify risk status and are compared against physician-based tools and genetic testing (germline genetic sequencing).
  • Диагностический тест Germline genetic sequencing for Cancer Predisposition Syndromes (CPS)
    All participants will provide a saliva or blood sample for germline genetic sequencing. The investigators will perform either whole-exome (WES) or whole-genome sequencing (WGS) and assess for pathogenic/ likely-pathogenic variants in known Cancer Predisposition Genes (CPS).
  • Диагностический тест MIPOGG Assessment
    The McGill Interactive Pediatric OncoGenetic Guidelines (MIPOGG) is a clinician-applied digital decision-support tool that uses patient age, tumor type, and clinical features to generate recommendations for referral to genetics. In this study, all participants will undergo MIPOGG assessment performed by the research team through the use of medical records. Results will be compared with those from the QUOCCAS questionnaire to evaluate concordance and potential equivalence in identifying children

Первичные конечные точки

  • Sensitivity and Specificity of the QUOCCAS Questionnaire for Identifying Cancer Predisposition Syndromes (CPS) [Срок оценки: Baseline to study completion, up to 36 months]
Вторичные конечные точки (3)
  • Genetic Literacy Score of Caregivers [Срок оценки: Baseline to study completion, up to 36 months]
  • Patient and Caregiver Satisfaction with Care and Information [Срок оценки: Baseline to study completion, up to 36 months]
  • Feasibility of Implementing QUOCCAS Questionnaire for Identifying Cancer Predisposition Syndromes and the Pre-Visit Preparation (PVP) Brochure [Срок оценки: At study completion, up to 36 months]

Критерии участия

Критерии включения

  • The investigators will include newly diagnosed patients who received a cancer diagnosis included in the International Classification of Childhood Cancer version 3 (ICCC3) criteria, treated at participating hospitals

Критерии исключения

  • Over 21 years of age

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Диагностика

Центры проведения

Швейцария · 1 центр
  • Inselspital, Universitäts Kinderklinik (University Children's Hospital) Bern — Bern

Идентификаторы

NCT: NCT07378423 · 2025-01346

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗