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Идёт набор NCT06008392

INTERogating Cancer for Etiology, Prevention and Therapy Navigation

— Наблюдательное Cancer Cancer Gene Mutation PAN Gene Mutation Hematopoietic and Lymphoid System Neoplasm

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: Pan-genomic Testing.
Кому может быть актуально
Состояния в реестре: Cancer, Cancer Gene Mutation, PAN Gene Mutation, Hematopoietic and Lymphoid System Neoplasm. 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN)

Обзор

This study is being done to identify markers and causes of cancer by analyzing patient's DNA (i.e., genetic material), RNA, plasma, tissues, or other samples that could be informative for patients with cancer. Cancer genetic testing is a series of tests that finds specific changes in cancer cells and normal cells in the body. Researchers may request to access these data as they explore how to better prevent, screen, or treat cancer. This study is also being done to create a biobank (library) of samples and information to learn more about treating cancer. Discovery of genetic variants in patients with cancer could result in opportunities for cancer prevention, earlier diagnosis or better therapy for cancer.

Вмешательства

  • Генная терапия Pan-genomic Testing
    Participants will be scheduled to review the study specifics, review consent and gather medical information. Once consented, samples will be collected. When the samples are received by Exact Sciences, DNA and RNA will be extracted, and sequencing will be performed. Following pan-genomic testing, participants will receive the full report with results from their care team and results will also be added to the patient's portal. If a germline finding is identified (positive pathogenic variant) the p

Первичные конечные точки

  • Genomic sequencing of tumor tissue and blood [Срок оценки: Baseline; 50 years]

Критерии участия

Критерии включения

GROUP A: Germline and Somatic Testing

  • Has Mayo Clinic medical record number
  • Confirmed cancer diagnosis
  • Germline and/or somatic tumor/blood testing has been ordered by the clinical provider (or clinical delegate)
  • Participant aware of cancer diagnosis
  • Able to provide informed consent
  • ≥ 18 years old
  • Ability to provide blood, saliva, bone marrow aspirate or hair follicle sample
  • Ability to provide archived tissue, if somatic testing has not already been completed
  • Note: if tissue unavailable participant may still enroll onto the study for the germline collection, or vice versa, if germline has already been completed may still enroll for somatic tissue/blood testing.

GROUP B: Germline testing only:

  • Has Mayo Clinic medical record number
  • Confirmed cancer diagnosis
  • Germline testing has been ordered by the clinical provider (or clinical delegate)
  • Participant aware of cancer diagnosis
  • Able to provide informed consent
  • ≥ 18 years old
  • Ability to provide blood, saliva, or hair follicle sample

GROUP C: Somatic tumor testing only:

  • Has Mayo Clinic medical record number,
  • Confirmed cancer diagnosis,
  • Somatic tumor/blood testing has been ordered by the clinical provider (or clinical delegate)
  • Participant aware of cancer diagnosis,
  • Able to provide informed consent,
  • ≥ 18 years old
  • Ability to provide archived tissue or blood for somatic tumor genomic profiling, if not already completed.

Group D: Clinical standard of care germline testing via genetic counselor:

  • Has Mayo Clinic medical record number,
  • Standard of care clinical visit with genetic counselor
  • Confirmed cancer diagnosis,
  • Germline testing has been ordered by the clinical provider (or clinical delegate)
  • Participant aware of cancer diagnosis,
  • Able to provide informed consent,
  • ≥ 18 years old
  • Ability to provide blood, saliva, or hair follicle sample

Group E: Previous Enrollment in IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810:

  • Enrolled in any of the following studies: IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810
  • Completed Riskguard, OncoExtra, Caris Assure, or Caris MI Profile or any combination of these tests.
  • Has Mayo Clinic medical record number,
  • Confirmed cancer diagnosis,
  • Participant aware of cancer diagnosis
  • Able to provide informed consent,
  • ≥ 18 years old

Критерии исключения

Note: Women who are pregnant or planning to become pregnant can take part in this study.

GROUP A: Germline and Somatic testing

  • Individuals who have situations that would limit compliance with the study requirements
  • Institutionalized (i.e. Federal Medical Prison)

GROUP B: Germline testing only

  • Individuals who have situations that would limit compliance with the study requirements
  • Institutionalized (i.e. Federal Medical Prison)
  • Prior germline genetic testing with a 100+ multi-gene panel within the last 1 year of enrollment

Group C: Somatic tumor testing only:

  • Individuals who have situations that would limit compliance with the study requirements,
  • Institutionalized (i.e. Federal Medical Prison),

Group D: Clinical standard of care germline testing via genetic counselor:

  • Individuals who have situations that would limit compliance with the study requirements,
  • Institutionalized (i.e. Federal Medical Prison)

Group E: Previous Enrollment in IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810:

  • Individuals who have situations that would limit compliance with the study requirements,
  • Institutionalized (i.e. Federal Medical Prison)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 3 центра
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Florida — Jacksonville
  • Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT06008392 · 22-008878 · NCI-2024-03113

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗