A Study on a Blood-based Dual-target Test for CRC Detection
NCT ID: NCT05508503
Last Updated: 2024-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1378 participants
OBSERVATIONAL
2022-10-21
2023-08-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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CRC group
patients with colorectal cancer
Test of methylated NTMT1 and MAP3K14-AS1
A dual-target test kit to detect methylated NTMT1 and MAP3K14-AS1 in blood samples.
FIT
Fecal immunochemical test（optional）
Control group
patients without colorectal cancer
Test of methylated NTMT1 and MAP3K14-AS1
A dual-target test kit to detect methylated NTMT1 and MAP3K14-AS1 in blood samples.
FIT
Fecal immunochemical test（optional）
Interventions
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Test of methylated NTMT1 and MAP3K14-AS1
A dual-target test kit to detect methylated NTMT1 and MAP3K14-AS1 in blood samples.
FIT
Fecal immunochemical test（optional）
Eligibility Criteria
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Exclusion Criteria
2. Colorectal cancer or colorectal adenoma with other malignancies；
3. Postoperative follow-up patients of colorectal cance with distant metastasis;
4. The sample size collected did not meet the detection requirements;
5. Other patients who are considered unsuitable for this study (such as pregnancy, high blood pressure, heart disease, etc., who are not suitable for colonoscopy due to physical condition).
ALL
Yes
Sponsors
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The Second Hospital of Hebei Medical University
OTHER
Qilu Hospital of Shandong University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Henan Provincial People's Hospital
OTHER
Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator, Clinical Professor
Principal Investigators
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Zhaoshen Li, MD
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital, Navy/Second Military Medical University
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Thierry AR, El Messaoudi S, Gahan PB, Anker P, Stroun M. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016 Sep;35(3):347-76. doi: 10.1007/s10555-016-9629-x.
Scholer LV, Reinert T, Orntoft MW, Kassentoft CG, Arnadottir SS, Vang S, Nordentoft I, Knudsen M, Lamy P, Andreasen D, Mortensen FV, Knudsen AR, Stribolt K, Sivesgaard K, Mouritzen P, Nielsen HJ, Laurberg S, Orntoft TF, Andersen CL. Clinical Implications of Monitoring Circulating Tumor DNA in Patients with Colorectal Cancer. Clin Cancer Res. 2017 Sep 15;23(18):5437-5445. doi: 10.1158/1078-0432.CCR-17-0510. Epub 2017 Jun 9.
Oster B, Thorsen K, Lamy P, Wojdacz TK, Hansen LL, Birkenkamp-Demtroder K, Sorensen KD, Laurberg S, Orntoft TF, Andersen CL. Identification and validation of highly frequent CpG island hypermethylation in colorectal adenomas and carcinomas. Int J Cancer. 2011 Dec 15;129(12):2855-66. doi: 10.1002/ijc.25951. Epub 2011 Apr 1.
Cao Y, Zhao G, Yuan M, Liu X, Ma Y, Cao Y, Miao B, Zhao S, Li D, Xiong S, Zheng M, Fei S. KCNQ5 and C9orf50 Methylation in Stool DNA for Early Detection of Colorectal Cancer. Front Oncol. 2021 Jan 29;10:621295. doi: 10.3389/fonc.2020.621295. eCollection 2020.
Chen H, Li N, Ren J, Feng X, Lyu Z, Wei L, Li X, Guo L, Zheng Z, Zou S, Zhang Y, Li J, Zhang K, Chen W, Dai M, He J; group of Cancer Screening Program in Urban China (CanSPUC). Participation and yield of a population-based colorectal cancer screening programme in China. Gut. 2019 Aug;68(8):1450-1457. doi: 10.1136/gutjnl-2018-317124. Epub 2018 Oct 30.
Wang Z, He Z, Lin R, Feng Z, Li X, Sui X, Gu L, Xia T, Zhou D, Zhao B, Li Y, Li Z, Bai Y. Evaluation of a plasma cell-free DNA methylation test for colorectal cancer diagnosis: a multicenter clinical study. BMC Med. 2024 Oct 8;22(1):436. doi: 10.1186/s12916-024-03662-y.
Other Identifiers
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2020CRC-cfDNA
Identifier Type: -
Identifier Source: org_study_id
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