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Идёт набор NCT04986657

Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS

Без фазы С лечением Whole Genome Sequencing Acute Myeloid Leukemia Myelodysplastic 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: ChromoSeq.
Кому может быть актуально
Состояния в реестре: Whole Genome Sequencing, Acute Myeloid Leukemia, Myelodysplastic Syndromes. 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
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Официальное название

A Prospective Study of Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS

Обзор

This is a single institution, prospective study of the whole genome sequencing assay, ChromoSeq. Using prospectively collected patient data, coupled with physician surveys, the investigators seek to determine the feasibility of implementing ChromoSeq in addition to standard genomic testing, for patients with the diagnoses of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Вмешательства

  • Устройство ChromoSeq
    Novel, streamlined whole genome sequencing approach

Первичные конечные точки

  • Sensitivity of ChromoSeq as measured by total number of recurrent structural variants identified [Срок оценки: Through completion of all ChromoSeq tests (estimated to be 15 months)]
  • Sensitivity of ChromoSeq as measured by total number of copy number alterations identified [Срок оценки: Through completion of all ChromoSeq tests (estimated to be 15 months)]
  • Sensitivity of ChromoSeq as measured by number of single nucleotide variants identified [Срок оценки: Through completion of all ChromoSeq tests (estimated to be 15 months)]
  • Sensitivity of ChromoSeq as measured by number of insertion-deletions identified [Срок оценки: Through completion of all ChromoSeq tests (estimated to be 15 months)]
  • Determine if risk-stratification using ChromoSeq correlates with overall-survival [Срок оценки: Through completion of follow-up for all patients (estimated to be 63 months)]
  • Determine if risk-stratification using ChromoSeq correlates with event-free survival [Срок оценки: Through completion of follow-up for all patients (estimated to be 63 months)]
  • Proportion of cases in which ChromoSeq provides new genetic information to the clinician [Срок оценки: Through completion of all ChromoSeq tests (estimated to be 15 months)]
  • ChromoSeq turnaround time [Срок оценки: Through completion of all ChromoSeq tests (estimated to be 15 months)]
  • Proportion of failed ChromoSeq assays [Срок оценки: Through completion of all ChromoSeq tests (estimated to be 15 months)]
Вторичные конечные точки (5)
  • Stakeholder perceptions of ChromoSeq [Срок оценки: Within 1 month after generation of ChromoSeq (estimated to be 2 months)]
  • Stakeholder perceptions of ChromoSeq as measured by the Acceptability of Intervention Measure [Срок оценки: When 100 genomes have been sequenced (estimated to be 12 months)]
  • Stakeholder perceptions of ChromoSeq as measured by the Intervention Appropriateness Measure [Срок оценки: When 100 genomes have been sequenced (estimated to be 12 months)]
  • Stakeholder perceptions of ChromoSeq as measured by the Feasibility of Implementation Measure [Срок оценки: When 100 genomes have been sequenced (estimated to be 12 months)]
  • Stakeholder perceptions of ChromoSeq as measured by the System Usability Scale [Срок оценки: When 100 genomes have been sequenced (estimated to be 12 months)]

Критерии участия

Inclusion Criteria Patient

  • Patient with a clinical suspicion for a new diagnosis of AML or MDS for whom the diagnostic molecular testing via the hematologic molecular algorithm (HMA) at BJH is requested or planned to be requested.
  • Adult patients 18 years or older.
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Inclusion Criteria Physician

  • Treating physician at Washington University School of Medicine who directs therapy for individuals with hematologic malignancies.
  • Able and willing to complete standardized questionnaires about usability, and stakeholder perceptions of ChromoSeq during the ChromoSeq implementation process.

Exclusion Criteria Patient

  • Younger than 18 years of age

Exclusion Criteria Physician

  • Does not treat patients at Washington University School of Medicine

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 1 центр
  • Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT04986657 · 202105123

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗