Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers (NCT05431621) | Clinical Trial Compass
CompletedNot Applicable
Establishment of Molecular Classification Models for Early Diagnosis of Digestive System Cancers
China2,430 participantsStarted 2020-11-15
Plain-language summary
This is a single blind, case control, multicenter study jointly developed by Zhongshan Hospital of Fudan University, Shanghai Public Health Clinical Center, Shanghai Xuhui Central Hospital, Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University, and Shanghai Singlera Genomics Company. The enrolled population will include positive group, precancerous lesions and healthy control group, which is expected to enroll 2,430 participants. The primary objective is to establish molecular testing methods for non-invasive screening and early diagnosis of digestive system cancers through ctDNA methylation and mutation, cfDNA and ctDNA fragment size, and end motif based model (for esophageal, gastric, colorectal cancer), and through ctDNA methylation detection, ctDNA low-pass WGS, miRNA7 and CTC detection and analysis technology based model (for hepatocellular carcinoma). The sensitivity and specificity of the models in cancer early detection will be evaluated.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Aged 18 to 80, no gender limitation, no pregnant or breastfeeding for women;
✓. Those who can accept gastroscopy and/or total colonoscopy;
✓. Newly-diagnosed patients who had not received surgery, radiotherapy, chemotherapy, targeted therapy or other anti-tumor intervention;
✓. Stop anticoagulant drugs such as warfarin, aspirin, and bolivir for 1 week, and stop low molecular weight heparin that day;
✓. No previous history of other tumor diseases, and no abnormalities in the liver and kidney;
✓. No major trauma requiring blood transfusion treatment within one week.
Exclusion criteria
✕. Previous esophageal cancer, stomach cancer, bowel cancer and gastrointestinal adenoma;
✕. Have a history of other cancers;
✕. Systemic inflammatory response syndrome;
What they're measuring
1
Establish ctDNA-targeted sequencing models for early detection of esophageal, gastric, colorectal and hepatocellular cancer, and evaluate the diagnosis value
Timeframe: assessed up to 1 year
2
Establish and evaluate the non-invasive early detection model for hepatocellular carcinoma
. Previously experienced esophageal, gastric or colorectal adenoma removal or tumor resection;
✕. Patients with Lynch syndrome in the family;
✕. A history of severe cardiovascular disease (e.g., previous myocardial infarction, coronary artery bypass grafting, coronary stenting, congestive heart failure, myocardial infarction within 6 months, or uncontrolled severe hypertension, etc.) who were deemed unsuitable for inclusion by the investigator;
✕. Have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug;
✕. Unsuitable for this trial determined by the researchers;