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Идёт набор NCT07224789

Liquid Biopsy for Early Detection of Colorectal Cancer Using Circular RNA

— Наблюдательное Colorectal 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: cf-circRNA assay.
Кому может быть актуально
Состояния в реестре: Colorectal 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Colorectal cancer (CRC) is a leading cause of cancer-related deaths worldwide. This study aims to develop a non-invasive liquid biopsy assay using plasma-derived cell-free circular RNAs (cf-circRNAs) for early and accurate detection of colorectal cancer.

Подробное описание

Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related mortality worldwide. Despite the proven benefit of screening colonoscopy, its invasive nature, high cost, and low adherence rates limit its use for population-level early detection. Current non-invasive screening tools, such as fecal occult blood testing and stool DNA assays, offer limited sensitivity, particularly for early-stage or right-sided colorectal tumors.

Therefore, there is a growing clinical need for a highly sensitive, minimally invasive, and patient-compliant diagnostic approach that can complement existing screening modalities.

Circular RNAs (circRNAs) are a novel class of endogenous non-coding RNAs characterized by covalently closed loop structures formed through back-splicing. Unlike linear RNAs, circRNAs are resistant to exonuclease-mediated degradation and are remarkably stable in body fluids. They exhibit tissue- and cancer-specific expression patterns, suggesting strong potential as non-invasive biomarkers.

Emerging evidence demonstrates that cell-free circRNAs (cf-circRNAs) circulate in plasma or serum either freely or encapsulated within extracellular vesicles such as exosomes. These cf-circRNAs retain the molecular signatures of their tumor of origin and can be reliably quantified using reverse transcriptase-quantitative PCR (RT-qPCR) or next-generation sequencing (NGS)-based platforms.

The CIRCLED study (Circular RNA for Colorectal Cancer Detection) is designed as a multi-center, case-control, observational study aiming to (1) identify diagnostic circRNA candidates from RNA sequencing, and (2) validate a cf-circRNA diagnostic panel capable of differentiating CRC patients from healthy individuals and those with benign colorectal diseases.

Вмешательства

  • Диагностический тест cf-circRNA assay
    Circular RNA detection in plasma or serum by RT-qPCR

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 cases (i.e., accuracy) [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Adults (≥18 years old)
  • Histologically confirmed colorectal cancer (Stage I-III)
  • Availability of pre-treatment plasma samples
  • Written informed consent provided

Критерии исключения

  • History of other active malignancies within the past 5 years
  • Poor sample quality or hemolysis
  • Inability to provide informed consent

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

США · 1 центр
  • City of Hope Medical Center — Duarte

Публикации

  • Dong Y, He D, Peng Z, Peng W, Shi W, Wang J, Li B, Zhang C, Duan C. Circular RNAs in cancer: an emerging key player. J Hematol Oncol. 2017 Jan 3;10(1):2. doi: 10.1186/s13045-016-0370-2. PMID 28049499
  • Qu S, Yang X, Li X, Wang J, Gao Y, Shang R, Sun W, Dou K, Li H. Circular RNA: A new star of noncoding RNAs. Cancer Lett. 2015 Sep 1;365(2):141-8. doi: 10.1016/j.canlet.2015.06.003. Epub 2015 Jun 5. PMID 26052092
  • Jeck WR, Sharpless NE. Detecting and characterizing circular RNAs. Nat Biotechnol. 2014 May;32(5):453-61. doi: 10.1038/nbt.2890. PMID 24811520
  • Chen LY, Wang L, Ren YX, Pang Z, Liu Y, Sun XD, Tu J, Zhi Z, Qin Y, Sun LN, Li JM. The circular RNA circ-ERBIN promotes growth and metastasis of colorectal cancer by miR-125a-5p and miR-138-5p/4EBP-1 mediated cap-independent HIF-1alpha translation. Mol Cancer. 2020 Nov 23;19(1):164. doi: 10.1186/s12943-020-01272-9. PMID 33225938
  • Xu H, Liu Y, Cheng P, Wang C, Liu Y, Zhou W, Xu Y, Ji G. CircRNA_0000392 promotes colorectal cancer progression through the miR-193a-5p/PIK3R3/AKT axis. J Exp Clin Cancer Res. 2020 Dec 14;39(1):283. doi: 10.1186/s13046-020-01799-1. PMID 33317596
  • Long F, Lin Z, Li L, Ma M, Lu Z, Jing L, Li X, Lin C. Comprehensive landscape and future perspectives of circular RNAs in colorectal cancer. Mol Cancer. 2021 Feb 3;20(1):26. doi: 10.1186/s12943-021-01318-6. PMID 33536039
  • Zhang Y, Luo J, Yang W, Ye WC. CircRNAs in colorectal cancer: potential biomarkers and therapeutic targets. Cell Death Dis. 2023 Jun 9;14(6):353. doi: 10.1038/s41419-023-05881-2. PMID 37296107
  • Keum N, Giovannucci E. Global burden of colorectal cancer: emerging trends, risk factors and prevention strategies. Nat Rev Gastroenterol Hepatol. 2019 Dec;16(12):713-732. doi: 10.1038/s41575-019-0189-8. Epub 2019 Aug 27. PMID 31455888

Идентификаторы

NCT: NCT07224789 · 23228/CIRCLE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗