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Идёт набор NCT07450612

Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection

— Наблюдательное Colorectal Cancer Adenoma Colon Adenoma Colon Polyp Colon Adenoma

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: BEACON.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer, Adenoma Colon, Adenoma Colon Polyp, Colon Adenoma. 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
Италия
Следующий шаг
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Обзор

This is an multicenter study that will test the diagnostic accuracy of a blood test (i.e., a liquid biopsy) for the diagnosis of colorectal cancer (CRC), advanced adenomas (AAs), as well as Lynch-syndrome associated cancers. Additionally, a pre-planned analysis will evaluate the use of this liquid biopsy as a tool for molecular residual disease monitoring purposes.

Подробное описание

Colorectal cancer (CRC) remains a significant public health burden as the third-most commonly diagnosed and second-deadliest malignancy. While CRC is potentially preventable through the removal of precursor lesions known as advanced adenomas (AAs), current screening modalities have limitations. The fecal immunochemical test (FIT) exhibits reduced sensitivity for early-stage CRC and AAs, primarily lowering mortality rather than incidence. Colonoscopy, while effective, is invasive, costly, and suffers from suboptimal adherence. Additionally, individuals with Lynch syndrome (LS), who carry a pathogenic germline variant in mismatch repair (MMR) genes, lack effective and reliable methods for early-stage detection of non-CRC tumors associated with the syndrome.

The rationale of this study, BEACON/2026, is to develop and validate two blood-based tests to address these clinical gaps. The first is a screening test sensitive to both CRC and AAs to complement existing screening options; the second is a multi-cancer early detection (MCED) test tailored to the LS spectrum. The central hypothesis is that a liquid biopsy approach combining cell-free microRNAs (cf-miRNAs, which are sensitive) and exosome-bound microRNAs (exo-miRNAs, which are specific) can effectively distinguish patients with AAs, CRC, and LS-associated cancers from controls.

This study follows the Early Detection Research Network (EDRN) recommendations for biomarker development, including biomarker discovery, prioritization, training, and independent validation (Phases I through III). The experimental design complies with PROBE recommendations for prospectively collected biospecimens that are blindly evaluated. The procedure involves the collection of peripheral blood to isolate RNA from plasma or serum for reverse transcription, quantitative polymerase chain reaction (RT-qPCR) analysis and machine-learning modeling . This non-invasive approach aims to provide a cost-effective, patient-friendly alternative to improve screening participation and disease monitoring

Вмешательства

  • Диагностический тест BEACON
    A panel of circulating microRNA, whose expression level is tested in cell-free and exosome-derived samples

Первичные конечные точки

  • Sensitivity [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (2)
  • Specificity [Срок оценки: Through study completion, an average of 1 year]
  • Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • All individuals included in the study need to have had a colonoscopy at the time of blood sampling.
  • Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
  • Received standard pathological and endoscopic diagnosis and assessment for cohort assignment

Критерии исключения

  • Lack of informed consent
  • Inflammatory bowel disease

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Италия · 4 центра
  • Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital — Milan
  • Prof Giulia Martina Cavestro, MD PhD — Milan
  • San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit — Milan
  • Dipartimento di Chirurgia Oncologica e Dipartimento di Oncologia Sperimentale Istituto Naz — Milan

Публикации

  • Ahlquist DA, Sargent DJ, Loprinzi CL, Levin TR, Rex DK, Ahnen DJ, Knigge K, Lance MP, Burgart LJ, Hamilton SR, Allison JE, Lawson MJ, Devens ME, Harrington JJ, Hillman SL. Stool DNA and occult blood testing for screen detection of colorectal neoplasia. Ann Intern Med. 2008 Oct 7;149(7):441-50, W81. doi: 10.7326/0003-4819-149-7-200810070-00004. PMID 18838724
  • Aziz Z, Wagner S, Agyekum A, Pumpalova YS, Prest M, Lim F, Rustgi S, Kastrinos F, Grady WM, Hur C. Cost-Effectiveness of Liquid Biopsy for Colorectal Cancer Screening in Patients Who Are Unscreened. JAMA Netw Open. 2023 Nov 1;6(11):e2343392. doi: 10.1001/jamanetworkopen.2023.43392. PMID 37971743
  • Barnell EK, Kang Y, Wurtzler EM, Griffith M, Chaudhuri AA, Griffith OL; Geneoscopy Scientists. Noninvasive Detection of High-Risk Adenomas Using Stool-Derived Eukaryotic RNA Sequences as Biomarkers. Gastroenterology. 2019 Sep;157(3):884-887.e3. doi: 10.1053/j.gastro.2019.05.058. Epub 2019 May 30. No abstract available. PMID 31154021
  • Barnell EK, Wurtzler EM, La Rocca J, Fitzgerald T, Petrone J, Hao Y, Kang Y, Holmes FL, Lieberman DA. Multitarget Stool RNA Test for Colorectal Cancer Screening. JAMA. 2023 Nov 14;330(18):1760-1768. doi: 10.1001/jama.2023.22231. PMID 37870871
  • Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins PMID 24553385
  • Carethers JM. Stool-Based Screening Tests for Colorectal Cancer. JAMA. 2023 Mar 14;329(10):839-840. doi: 10.1001/jama.2023.0547. PMID 36800187
  • Chung DC, Gray DM 2nd, Singh H, Issaka RB, Raymond VM, Eagle C, Hu S, Chudova DI, Talasaz A, Greenson JK, Sinicrope FA, Gupta S, Grady WM. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983. doi: 10.1056/NEJMoa2304714. PMID 38477985
  • Imperiale TF, Porter K, Zella J, Gagrat ZD, Olson MC, Statz S, Garces J, Lavin PT, Aguilar H, Brinberg D, Berkelhammer C, Kisiel JB, Limburg PJ; BLUE-C Study Investigators. Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):984-993. doi: 10.1056/NEJMoa2310336. PMID 38477986

Идентификаторы

NCT: NCT07450612 · BEACON/2026

Первоисточники (государственные реестры)

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