Colorectal Cancer Clinical Trial
Official title:
Non-invasive Auxiliary Diagnosis of Colorectal Cancer and Advanced Adenoma by Detecting Cancer-specific Methylation Signatures in Plasma ctDNA
Colorectal cancer is a common malignant tumor of the digestive tract. It is still a
challenging task to detect colorectal cancer at an early stage. Studies have found that DNA
methylation has a relationship with the occurrence and development of tumors. Singlera
Genomics Inc. has invented the proprietary methyl-Titan sequencing technology and developed a
detection method for colorectal cancer and advanced adenoma (Adenoma/Colorectal cancer Early
detection, ACE) using the cancer-specific methylation markers. ACE is a blood-based
non-invasive diagnostic technique. It has high compliance rate compared with colonoscopy, and
sampling is more convenient than stool testing. It also has much higher sensitivity compared
to existing blood testing methods.
The current study plans to use ACE method to analyze ctDNA in the blood for the
cancer-specific DNA methylation markers to aid in the differential diagnosis of patients with
colorectal cancer or adenoma. This technique will greatly reduce the discomfort in the
diagnosis of suspected patients and improve the diagnosis of high-risk population of
colorectal cancer.
The goals of this study are: 1) to establish a detection system based on plasma ctDNA
methylation sequencing technology for the auxiliary diagnosis of colorectal cancer and
adenoma, 2) to assess the diagnostic value of plasma ctDNA methylation signature for
colorectal cancer and adenoma, and 3) to assess the association of plasma ctDNA methylation
signals with colonoscopy results and pathological results of surgical specimens.
A total of 1300 patients (700 cases positive and 600 cases negative) aging between 45 and 80
years old will be enrolled. Colonoscopy will be performed to determine whether patients are
positive or negative. Positive patients who need surgical resection will be further
classified according to their surgical histopathological results. For negative patients, the
type of lesion will be clarified. The plasma samples of all subjects will be analyzed for
cancer-specific ctDNA methylation profiles. Based on the results of plasma ctDNA methylation
test, the risks of colorectal cancer of the enrolled subjects are scored. Combined with the
grouping information, the clinical application value of the cancer-specific methylation
profile for early cancer diagnosis will be assessed.
Status | Recruiting |
Enrollment | 1300 |
Est. completion date | September 30, 2020 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Age 45~80 years old, gender is not limited, women are not in pregnancy and lactation; 2. Willing to accept a full colonoscopy; 3. The patients enrolled are newly diagnosed patients who did not receive surgery, radiotherapy, chemotherapy, targeted therapy or other tumor-related intervention; 4. The anticoagulant drugs such as warfarin, aspirin and Plavix were stopped for 1 week, and low molecular weight heparin was stopped on the same day; 5. No history of other cancer diseases, normal liver and kidney function; 6. No major trauma requiring blood transfusion treatment occurred within one week. Exclusion Criteria: 1. Have had colorectal cancer or intestinal adenoma before; 2. Have other cancer history; 3. Previously undergoing a colon and rectal resection (except for sigmoid diverticulosis); 4. Patients with Lynch syndrome in the family; 5. History of severe cardiovascular disease (eg previous myocardial infarction, coronary artery bypass grafting or coronary stenting, history of congestive heart failure; myocardial infarction within 6 months, uncontrolled severe hypertension, etc.), or patients that the investigator determines not suitable for enrollment; 6. Participated in "interventional" clinical trials and have taken test drugs over the past 30 days; 7. Patients that the investigator determines not suitable for enrollment; 8. Failure to follow the test plan to collect blood on time; 9. The blood collection sample does not meet the requirements. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Zhongshang Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital | Dalian University Affiliated Xinhua Hospital, Fudan University, Guangzhou First People's Hospital, Singlera Genomics Inc., West China Hospital |
China,
1. Shaukat A, Mongin SJ, Geisser MS, et al. Long-term mortality after screening for colorectal cancer. N Engl J Med, 2013; 369(12): 1106-1114. 2. Brenner H, Tao S. Superior diagnostic performance of faecal immunochemical tests for haemoglobin in a head-to-head comparison with guaiac based faecal occult blood test among 2235 participants of screening colonoscopy. Eur J Cancer, 2013, 49(14): 3049-3054. 3. National Cancer Institute's SEER database. [EB/OL]. http://seer.cancer.gov/. Accessed August 26, 2016. 4. M. Esteller. Molecular origins of cancer: epigenetics in cancer. New Engl J Med, 2008; 358(11): 1148-1096. 5. D. J. Weisenberger, K. D. Siegmund, et al. CpG island methylator phenotype underlies sporadic microsatellite instability and is tightly associated with BRAF mutation in colorectal cancer. Nature Genetics, 2006; 38(7): 787-793. 6. E. E. Torlakovic, J. D. Gomez, et al. Sessile serrated adenoma(SSA) vs traditional serrated adenoma(TSA). American Journal of Surgical Pathology, 2008; 32(1): 21-29. 7. Hironori Aoki, Eiichiro Yamamoto, et al. Epigenetic silencing of SMOC1 in traditional serrated adenoma and colorectal cancer. Oncotarget, 2018; 9(4): 4707-4721. 8. Genetic/Familial High-Risk Assessment: Colorectal. NCCN Guidelines. Version 3. 2017.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assay sensitivity and specificity for colorectal cancer and advanced adenoma | Assay sensitivity and specificity will be determined using colonoscopy and histopathological results as the gold standard. The following formula will be used to calculate sensitivity and specificity: sensitivity= TP/(TP+FN); specificity= TN/(TN+FP) | August 17, 2018- September 30, 2020 |
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