Clinical trial NCT05875584: Exploratory Study of a Novel Based rbcDNA Liquid Biopsy Technique for Colorectal Cancer Early Detection
Official title: Exploratory Study of a Novel Based rbcDNA Liquid Biopsy Technique for Colorectal Cancer Early Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Adenomatous Polyps
Adenoma
Advanced Adenoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Timing Biotech Co.Ltd.
First posted: 2023-05-25
Enrollment: 598
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects advanced adenomas and patients with confirmed CRC

Brief summary: Exploration of a novel rbcDNA liquid biopsy technique for early detection of colorectal cancer is a promising development in the field of disease diagnosis and screening. This technique has the potential to establish an efficient and sensitive system for the early detection of colorectal cancer, which can provide a new perspective for individual health monitoring.

Detailed description: Patients who are at high risk of developing colorectal cancer and willing to undergo colonoscopy examination will be asked to collect a stool sample prior to bowel preparation for commercially available FIT (fecal immunochemical test) assay, as well as a blood sample for rbcDNA testing. The colonoscopy and histopathologic examination will be used as a reference for the results obtained from these tests.

Eligibility criteria: Inclusion Criteria:

1. Age:40-74Years
2. Sex:All
3. Willing to provide written consent
4. Plan to undergo colorectaloscopy or surgical treatment and be able to provide a complete medical history and cooperate with blood sampling and follow-up visits，other operation.

For advanced adenomas (AA) group:

1. Adenomatous polyps with ≥25% villous component, high-grade dysplasia (HGD), or a diameter ≥10 mm were considered AA. Sessile serrated lesions with diameters ≥10 mm.
2. treatment-naive
3. No other comorbid tumors

For CRC group:

1. Confirmed CRC patients
2. treatment-naive
3. No other comorbid tumors

Exclusion Criteria:

1. Patients with colorectal cancer who have received prior treatment.
2. FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis
3. Participants taking anticoagulants such as aspirin or warfarin, or those with coagulation disorders.
4. Prior history of colonoscopy within the past 5 years and removal of lesions
5. Pregnancy or intestinal infarction people
6. Unable to provide informed consent
7. Participants in other clinical trials or who have participated in other clinical trials within 60 days.
8. Unable to provide stool sample and follow-up visits.
9. Presence of major infectious diseases (e.g. HIV, etc.)

Primary outcomes:
measure: Evaluating the sensitivity, specificity, and accuracy of rbcDNA in colorectal cancer screening
timeFrame: Through study completion，an average of 1 year
Secondary outcomes:
measure: Sensitivity of the rbcDNA screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC
timeFrame: Through study completion，an average of 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: