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OpenTrials
Completed

NCT Number: NCT05875584

Exploratory Study of a Novel Based rbcDNA Liquid Biopsy Technique for Colorectal Cancer Early Detection

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age:40-74Years
  • Sex:All
  • Willing to provide written consent
  • 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:

  • 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.
  • treatment-naive
  • No other comorbid tumors

For CRC group:

  • Confirmed CRC patients
  • treatment-naive
  • No other comorbid tumors

Exclusion criteria

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

Treatment and study plan

rbcDNA test

Diagnostic Test

fecal immunochemical test

Other names: FIT

Primary outcomes

  1. Evaluating the sensitivity, specificity, and accuracy of rbcDNA in colorectal cancer screening

    Time frame: Through study completion,an average of 1 year

    A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The rbcDNA test was deployed to a composite score. The tests were processed independently of colonoscopy procedure.

Secondary outcomes

  1. Sensitivity of the rbcDNA screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC

    Time frame: Through study completion,an average of 1 year

    A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The rbcDNA and FIT test were performed.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Timing Biotech Co.Ltd.

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 25, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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