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A prospective study on the application of Multi-target Stool FIT-DNA Test (ColoClear) in colorectal cancer screening and the practical verification of genetic and lifestyle factors

A prospective study on the application of Multi-target Stool FIT-DNA Test (ColoClear) in colorectal cancer screening and the practical verification of genetic and lifestyle factors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DDD-17014145
Enrollment
Unknown
Registered
2017-12-25
Start date
2017-12-21
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal tumor

Interventions

Sponsors

Colorectal surgery department,Cancer Institute and Hospital,Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 74 Years

Inclusion criteria

Inclusion criteria: ?Enrollees included patients with colorectal cancer, advanced adenoma, and spouses and first-degree relatives of patients with colorectal cancer who were in the colorectal surgery and general surgery centers in each center. First-degree relatives include: parents, children, and siblings (same parents). ?Age 40-74 years old; ?Patients with colorectal cancer and advanced adenoma: all require electronic colonoscopy and pathological diagnosis; ?Spouse of patients with colorectal cancer: over 15 years of marriage age; ? The spouse group and the first-degree relative group must be related to the patient group, but not necessarily 1:1:1.

Exclusion criteria

Exclusion criteria: ? Enrollees cannot or will not accept colonoscopy (with colonoscopy contraindications). ?There are other serious diseases of the digestive tract, such as Crohn's disease and ulcerative colitis. ?Diagnosed patients or their spouses and first-degree relatives were diagnosed with colon cancer-related genetic syndromes, such as hereditary non-polyposis colorectal cancer syndrome (HNPCC), familial mucosal skin pigmentation, gastrointestinal tract Polyposis (Peutz-Jeghers Syndrome), MYH-Associated Polyposis (MYH-Associated Polyposis), Gardner syndrome, Turcot syndrome, Cowden syndrome, Juvenile Polyposis, Cronkhinte-Canada syndrome, Neurofibromatosis, or familial polyp proliferation. ?Severe heart, liver, lung, kidney, blood, and endocrine system diseases. ? Pregnant women, lactating women or women of childbearing age who are about to conceive. ? Patients with other malignant tumors at the same time. ? Subjects who have undergone surgery, radiotherapy, and chemotherapy for bowel cancer and precancerous lesions. ?The research physician believes that there are any circumstances that are not suitable for selection.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Positive predictive value;Negative predictive value;Coincidence Rate;Morbidity;

Countries

China

Contacts

Public ContactWang Xishan

Cancer Institute and Hospital,Chinese Academy of Medical Sciences

wxshan1208@126.com13552367779

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026