Colorectal CancerNCT05875584
Exploratory Study of a Novel Based rbcDNA Liquid Biopsy Technique for Colorectal Cancer Early Detection
An observational study of Colorectal Cancer and Adenomatous Polyps, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Adenomatous Polyps, Adenoma
- What is being tested?
- rbcDNA test
- How many people
- 598 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2023to 10 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects advanced adenomas and patients with confirmed CRC
Who may be able to join
- 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.
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- treatment-naive
- No other comorbid tumors
- For CRC group:
- Confirmed CRC patients
- treatment-naive
- No other comorbid tumors
Who cannot join
- 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
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- 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.)
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
About this study
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.
Read the 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.
- Conditions
- Colorectal Cancer, Adenomatous Polyps, Adenoma, Advanced Adenoma
- Being tested
- rbcDNA test
- Medical subject headings
- Colorectal Neoplasms, Adenomatous Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rbcDNA testDiagnostic test
Also called FIT
fecal immunochemical test
| Study group | Role | What they receive |
|---|---|---|
| advanced adenomas (AA) group | Prospective enrollment of subjects with advanced adenomas Receives: Diagnostic Test: rbcDNA test | |
| CRC group | Retrospective enrollment of subjects with confirmed colorectal cancer Receives: Diagnostic Test: rbcDNA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the sensitivity, specificity, and accuracy of rbcDNA in colorectal cancer screening
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.
Measured: Through study completion，an average of 1 year
Secondary outcomes (1)
Sensitivity of the rbcDNA screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC
A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The rbcDNA and FIT test were performed.
Measured: Through study completion，an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start18 May 2023
- Primary completion28 Dec 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Timing Biotech Co.Ltd.
- Responsible party
- Principal investigator, Jun Li, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875584
- Sponsor's protocol ID
- SAHZhejiangU Timing
- Status last verified
- Aug 2024
- First submitted
- 4 May 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of a Novel Based rbcDNA Liquid Biopsy Technique for Colorectal Cancer Early Detection
- ClinicalTrials.gov ID
- NCT05875584
- Acronym / sponsor ID
- SAHZhejiangU Timing
- Conditions
- Colorectal Cancer, Adenomatous Polyps, Adenoma, Advanced Adenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Timing Biotech Co.Ltd.
- Study start
- 18 May 2023 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| advanced adenomas (AA) group | – | Diagnostic Test: rbcDNA testProspective enrollment of subjects with advanced adenomas |
| CRC group | – | Diagnostic Test: rbcDNA testRetrospective enrollment of subjects with confirmed colorectal cancer |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects advanced adenomas and patients with confirmed CRC
Key inclusion criteria (12 listed)
- 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.
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rbcDNA testAlso: FITfecal immunochemical test | Diagnostic test | CRC group, advanced adenomas (AA) group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Adenomatous Polyps, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the sensitivity, specificity, and accuracy of rbcDNA in colorectal cancer screening (time frame: Through study completion，an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.