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Идёт набор NCT06989814

Smart Measurement of Circulating Tumor DNA

Без фазы С лечением Colorectal Neoplasms Colorectal Neoplasms Malignant Colorectal Neoplasms, Hereditary Nonpolyposis Hereditary Nonpolyposis Colon Cancer

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: Blood Product.
Кому может быть актуально
Состояния в реестре: Colorectal Neoplasms, Colorectal Neoplasms Malignant, Colorectal Neoplasms, Hereditary Nonpolyposis, Hereditary Nonpolyposis Colon Cancer. 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
Нидерланды
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

Smart Measurement of Circulating Tumor DNA: a Tumor-agnostic Computational Tool to Improve Colorectal Cancer Care

Обзор

The goal of this study is to develop a blood-test which can detect colorectal cancer in early stages. Participants will be asked to take an extra blood test, which will be analyzed further in the lab.

Подробное описание

Lynch Syndrome (LS) carriers have a predisposition to develop various types of cancer, especially colorectal cancer (CRC) and endometrial cancer (EC). LS patients are advised to undergo surveillance by colonoscopy every 2 year and gynaecological surveillance. This surveillance is deemed burdensome and fails to detect a small part of the developing CRCs and the majority of extra-colonic cancers. To ensure prevention and early detection of cancer, a reliable and accessible test is needed. Recent studies have shown the potential of the detection of tumor-derived DNA fragments (circulating tumor DNA; ctDNA). Various molecular characteristics can be used to discriminate ctDNA from healthy circulating cell-free DNA. Current ctDNA assays with the highest sensitivity and specificity to detect for example minimal residual disease (MRD) after surgery are mostly tumor-informed, which means prior information is needed from the tumor tissue about the molecular alterations present.

As this information is not available for the detection of newly arising tumors, the aim of this study is to evaluate the use of an optimized combination of tumor agnostic ctDNA characteristics for the detection of newly developing tumors.

Вмешательства

  • Диагностический тест Blood Product
    An (extra) blood test will be done on participants. This will be analyzed for circulating tumor DNA (ctDNA) via a multi-omics approach.

Первичные конечные точки

  • Estimated ctDNA fractions in blood [Срок оценки: Measurement at baseline]
  • Tumor pathology [Срок оценки: Measurement at baseline]

Критерии участия

Критерии включения

(suspect) Lynch Syndrome carriers who:

  • Have proven Lynch Syndrome (MMR-gene or EPCAM mutation), or have a proven microsatellite instability high (MSI-H)tumor;
  • Are at least 18 years old; Have been diagnosed with any form of cancer at the time of inclusion, but have had no treatment yet;
  • Have granted informed consent to participate in this study.

Критерии исключения

(suspect) Lynch Syndrome carriers who:

  • Are unwilling to undergo extra blood sampling;
  • Are under the age of 18;
  • Have no newly diagnosed tumors at time of inclusion;
  • Have been treated for their tumor at time of inclusion;
  • Are not able to read or understand Dutch language or are mentally not capable.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

Нидерланды · 2 центра
  • Leiden University Medical Center — Leiden
  • Erasmus MC — Rotterdam

Публикации

  • Mouliere F, Chandrananda D, Piskorz AM, Moore EK, Morris J, Ahlborn LB, Mair R, Goranova T, Marass F, Heider K, Wan JCM, Supernat A, Hudecova I, Gounaris I, Ros S, Jimenez-Linan M, Garcia-Corbacho J, Patel K, Ostrup O, Murphy S, Eldridge MD, Gale D, Stewart GD, Burge J, Cooper WN, van der Heijden MS, Massie CE, Watts C, Corrie P, Pacey S, Brindle KM, Baird RD, Mau-Sorensen M, Parkinson CA, Smith C PMID 30404863
  • Deger T, Boers RG, de Weerd V, Angus L, van der Put MMJ, Boers JB, Azmani Z, van IJcken WFJ, Grunhagen DJ, van Dessel LF, Lolkema MPJK, Verhoef C, Sleijfer S, Martens JWM, Gribnau J, Wilting SM. High-throughput and affordable genome-wide methylation profiling of circulating cell-free DNA by methylated DNA sequencing (MeD-seq) of LpnPI digested fragments. Clin Epigenetics. 2021 Oct 20;13(1):196. do PMID 34670587
  • Schrag D, Beer TM, McDonnell CH 3rd, Nadauld L, Dilaveri CA, Reid R, Marinac CR, Chung KC, Lopatin M, Fung ET, Klein EA. Blood-based tests for multicancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023 Oct 7;402(10409):1251-1260. doi: 10.1016/S0140-6736(23)01700-2. PMID 37805216
  • Eikenboom EL, Wilting SM, Deger T, Srebniak MI, Van Veghel-Plandsoen M, Boers RG, Boers JB, van IJcken WFJ, Gribnau JH, Atmodimedjo P, Dubbink HJ, Martens JWM, Spaander MCW, Wagner A. Liquid Biopsies for Colorectal Cancer and Advanced Adenoma Screening and Surveillance: What to Measure? Cancers (Basel). 2023 Sep 17;15(18):4607. doi: 10.3390/cancers15184607. PMID 37760576

Идентификаторы

NCT: NCT06989814 · NL87476.078.24 · 14976

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗