Colorectal CancerCLEAR-CNCT04287335
Multitarget Stool FIT-DNA Study for Colorectal Cancer Early Screening in China
An observational study of Colorectal Cancer and Adenomatous Polyps, run by Zhejiang University at 8 sites in China.
Trial summary
The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed multitarget FIT-DNA Colorectal Cancer (CRC) screening test (ColoClear) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients, using colonoscopy as the reference… 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?
- Multitarget stool FIT-DNA test - ColoClear, FIT and Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 4,758 participants
- Where
- 8 sitesChina
- Study dates
- 18 Sep 2018to 13 Sep 2020
- 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 with high risk of developing CRC and patients with confirmed CRC
Who may be able to join
- Willing to provide written consent
- Able to provide stool sample
- For high risk CRC screening group:
- Scheduled for colonoscopy voluntarily or by physician prescription
- CRC high risk profile as defined below:
- History of FIT positivity
Show all 11Show fewer
- Family history of CRC
- Any of two of the following clinical symptoms: chronic constipation/diarrhea, stool with mucous, chronic appendicitis, chronic bilary track diseases, mental stress
- For CRC group:
- Confirmed CRC patients
- No prior treatment with chemotherapy, radiotherapy, and prior to any surgical procedures
Who cannot join
- Unwilling to provide stool samples
- FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis
- Prior history of colonoscopy within the past 5 years and removal of lesions
- History of CRC
- other conditions deemed not suited for the study by investigators
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
West China Hospital of Sichuan University
Chengdu, Sichuan
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Shanxi Provincial People's Hospital
Taiyuan, Shanxi
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Hubei Cancer Hospital
Wuhan, Hubei
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: Stool KRAS Mutation, BMP3/NDRG4 Methylation and FIT Panel Test for the Detection of Colorectal Advanced Neoplasia in High Risk Chinese Patients
The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed multitarget FIT-DNA Colorectal Cancer (CRC) screening test (ColoClear) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multitarget FIT-DNA test with commercially available FIT (Fecal Immunochemical Test) assay in detecting advanced neoplasia.
Read the detailed description
The study will be carried out in 8 tier-3A hospitals throughout China. Patients who are at high risk of developing colorectal cancer and willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for multitarget FIT-DNA test and commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference.
- Conditions
- Colorectal Cancer, Adenomatous Polyps, Adenoma, Advanced Adenoma
- Being tested
- Multitarget stool FIT-DNA test - ColoClear, FIT, Colonoscopy
- Keywords
- Cancer, Colorectal Cancer, Colorectal Neoplasms, Adenomatous Polyps, Adenoma, Advanced adenoma, Gastrointestinal Diseases, Colonic Diseases, Neoplasms, Digestive System Diseases, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Intestinal Diseases, Rectal Diseases, Glandular and Epithelial, Neoplasms by Histologic Type
- Medical subject headings
- Colorectal Neoplasms, Adenomatous Polyps, Adenoma, Neoplasms, Gastrointestinal Diseases, Colonic Diseases, Digestive System Diseases, Intestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multitarget stool FIT-DNA test - ColoClearDiagnostic test
Multitarget stool FIT-DNA test
FITDiagnostic test
fecal immunochemical test
ColonoscopyProcedure or surgery
diagnostic colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| High risk CRC screening group | Prospective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer Receives: Diagnostic Test: Multitarget stool FIT-DNA test - ColoClear; Diagnostic Test: FIT; Procedure: Colonoscopy | |
| CRC group | Retrospective enrollment of subjects with confirmed colorectal cancer Receives: Diagnostic Test: Multitarget stool FIT-DNA test - ColoClear; Diagnostic Test: FIT; Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy
A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, plus a hemoglobin immunoassay. A logistic-regression algorithm incorporating all the above parameters was deployed to compute a single composite score, with values of 165 or more considered to be positive. The tests were processed independently of colonoscopy procedure.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Sensitivity of the ColoClear 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 ColoClear and FIT test were performed on the same stool sample.
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 posted27 Feb 2020
- Study start18 Sep 2018
- Primary completion8 Dec 2019
- Study completion13 Sep 2020
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 Zhejiang UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 4,758 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- New Horizon Health Technology Co., Ltd, Beijing Mingze Technology Co., Ltd.
- Responsible party
- Principal investigator, Ding Ke-Feng, Zhejiang University
- Investigators
- Kefeng Ding, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287335
- Sponsor's protocol ID
- CLEAR-C 2018
- Acronym
- CLEAR-C
- Status last verified
- Dec 2020
- First submitted
- 20 Feb 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stool KRAS Mutation, BMP3/NDRG4 Methylation and FIT Panel Test for the Detection of Colorectal Advanced Neoplasia in High Risk Chinese Patients
- ClinicalTrials.gov ID
- NCT04287335
- Acronym / sponsor ID
- CLEAR-C / CLEAR-C 2018
- Conditions
- Colorectal Cancer, Adenomatous Polyps, Adenoma, Advanced Adenoma
- Keywords
- Cancer, Colorectal Cancer, Colorectal Neoplasms, Adenomatous Polyps, Adenoma, Advanced adenoma, Gastrointestinal Diseases, Colonic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,758 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- New Horizon Health Technology Co., Ltd, Beijing Mingze Technology Co., Ltd.
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 8 Dec 2019 (actual)
- Study completion
- 13 Sep 2020 (actual)
- First posted
- 27 Feb 2020 (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.
The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed multitarget FIT-DNA Colorectal Cancer (CRC) screening test (ColoClear) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multitarget FIT-DNA test with commercially available FIT (Fecal Immunochemical Test) assay in detecting advanced neoplasia.
Detailed description
The study will be carried out in 8 tier-3A hospitals throughout China. Patients who are at high risk of developing colorectal cancer and willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for multitarget FIT-DNA test and commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk CRC screening group | – | Diagnostic Test: Multitarget stool FIT-DNA test - ColoClear, Diagnostic Test: FIT, Procedure: ColonoscopyProspective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer |
| CRC group | – | Diagnostic Test: Multitarget stool FIT-DNA test - ColoClear, Diagnostic Test: FIT, Procedure: ColonoscopyRetrospective 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 with high risk of developing CRC and patients with confirmed CRC
Key inclusion criteria (11 listed)
- Willing to provide written consent
- Able to provide stool sample
- Scheduled for colonoscopy voluntarily or by physician prescription
- CRC high risk profile as defined below:
- History of FIT positivity
Key exclusion criteria (5 listed)
- Unwilling to provide stool samples
- FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis
- Prior history of colonoscopy within the past 5 years and removal of lesions
- History of CRC
- other conditions deemed not suited for the study by investigators
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 |
|---|---|---|
| Multitarget stool FIT-DNA test - ColoClearMultitarget stool FIT-DNA test | Diagnostic test | CRC group, High risk CRC screening group |
| FITfecal immunochemical test | Diagnostic test | CRC group, High risk CRC screening group |
| Colonoscopydiagnostic colonoscopy | Procedure or surgery | CRC group, High risk CRC screening group |
Primary outcome
Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy
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 DNA test includes molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, plus a hemoglobin immunoassay. A logistic-regression algorithm incorporating all the above parameters was deployed to compute a single composite score, with values of 165 or more considered to be positive. The tests were processed independently of colonoscopy procedure.
1 secondary outcome
Sensitivity of the ColoClear 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 8 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Kefeng Ding, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
8 sites 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 Zhejiang University at 8 sites 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 11 inclusion and 5 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 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy (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 8 Dec 2020.