Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| 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 |
Not provided
Not provided
Not provided
Not provided
To evaluate the effectiveness and accuracy of the ctDNA dual-target test kit in a large case-control cohort for the detection of colorectal cancer and advanced adenomas.
Usually, colorectal cancers (CRCs) diagnosed in their early stages are curable, especially precancerous lesions (adenomas, polyps) that can be removed during a colonoscopy.However, due to low patient compliance and limited resources, colonoscopy is not feasible for screening the average-risk population. gFOBT/FIT are limited by their low sensitivity and high false-positive rate. Compared to colonoscopy and stool DNA tests, blood-based methylation tests showed greater patient compliance and convenience. Hypermethylated NTMT1 and MAP3K14-AS1 were found in multiple cohorts of CRC samples in our previous study. In this study, we aimed to evaluate the effectiveness and accuracy of the ctDNA dual-target(NTMT1 and MAP3K14-AS1) test kit in 5 tertiary hospitals around china for the detection of colorectal cancer and advanced adenomas. Fecal immunochemical test (FIT) will also privided to participants in the study. Sanger sequencing would be performed to evalute the accuracy of the dual-target methylation detection test kit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRC group | patients with colorectal cancer |
| |
| Control group | patients without colorectal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test of methylated NTMT1 and MAP3K14-AS1 | Diagnostic Test | A dual-target test kit to detect methylated NTMT1 and MAP3K14-AS1 in blood samples. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Sensitivity (for CRC and\or advanced precancerous neoplasm) of this blood-based methylation dual-target test. A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. Other clinically acceptable diagnostic criteria for non-intestinal diseases. | Through study completion, an average of 1 year. |
| Specificity | Specificity (for CRC and\or advanced precancerous neoplasm) of this blood-based methylation dual-target test. A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. Other clinically acceptable diagnostic criteria for non-intestinal diseases. | Through study completion, an average of 1 year. |
| Accuracy | Accuracy of the kit for methylation detection. Validation of the methylation status of MTNT1 and MAP3K14-AS1 by Sanger sequencing. | Through study completion, an average of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Combined sensitivity | Sensitivity when combined the blood-based methylation dual-target test with FIT | Through study completion, an average of 1 year. |
| Combined specificity | Specificity when combined the blood-based methylation dual-target test with FIT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients with colorectal cancer or subjects who referred to the outpatient and received colonoscopy.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li, MD | Changhai Hospital, Navy/Second Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27392603 | Background | 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. | |
| 28600478 | Background | 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. |
Not provided
Not provided
undecided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| Henan Provincial People's Hospital | OTHER |
Not provided
Not provided
Not provided
| FIT | Diagnostic Test | Fecal immunochemical test(optional) |
|
| Through study completion, an average of 1 year. |
| 21400501 | Background | 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. |
| 33585248 | Background | 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. |
| 30377193 | Result | 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. |
| 39379942 | Derived | 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |