Colorectal PolypNCT03750617
Web-Mediated Risk Assessment for Endoscopic Screening of Colorectal Polyps
A study testing pre-endoscopic screening risk assessment in people with Colorectal Polyp, run by State Key Laboratory of Cancer Biology at 1 site in China.
Trial summary
Colorectal polyps are risk factors for cancer. Early detection of polyps is critical for colorectal cancer management. However, the diagnosis rate of patients with colorectal polyps is still low. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Polyp
- What is being tested?
- pre-endoscopic screening risk assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 1 Dec 2020
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65.
- Signed informed consent
Who cannot join
- Severe back ground disease including malignancy.
- State after gastric surgery.
- COPD, CHF, CRF and any disease with respiratory disturbances.
- Deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
State Key laboratory of Cancer Biology
Xi'an, Shaanxi, 710032
Dake Chu, M.D., chudake@hotmail.com
About this study
Official title: Randomized Trial Comparing Gastroscopy Following Web-Mediated Risk Assessment With Routine Endoscopy Screening of Colorectal Polyps
Colorectal polyps are risk factors for cancer. Early detection of polyps is critical for colorectal cancer management. However, the diagnosis rate of patients with colorectal polyps is still low. Therefore, we design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve diagnosis rate of colorectal polyps.
- Conditions
- Colorectal Polyp
- Being tested
- pre-endoscopic screening risk assessment
- Keywords
- Colorectal Polyp, Screening, Risk assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-endoscopic screening risk assessmentDiagnostic test
pre-endoscopic screening risk assessment
| Study group | Role | What they receive |
|---|---|---|
| pre-endoscopic screening risk assessment | Experimental | Not described Receives: Diagnostic Test: pre-endoscopic screening risk assessment |
| routine screening | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic rate of patients with polyps
Diagnostic rate of patients with polyps
Measured: 2 year
Secondary outcomes (1)
Number and characteristics of polyps detected
Characterization of types of polyps
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Dec 2017
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Key Laboratory of Cancer Biology
- Sponsor type
- Research network
- Collaborators
- Xijing Hospital, Tang-Du Hospital
- Responsible party
- Principal investigator, Dake Chu, State Key Laboratory of Cancer Biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750617
- Sponsor's protocol ID
- xjtu-20170815
- Status last verified
- Nov 2018
- First submitted
- 27 Mar 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Gastroscopy Following Web-Mediated Risk Assessment With Routine Endoscopy Screening of Colorectal Polyps
- ClinicalTrials.gov ID
- NCT03750617
- Acronym / sponsor ID
- xjtu-20170815
- Conditions
- Colorectal Polyp
- Keywords
- Colorectal Polyp, Screening, Risk assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- State Key Laboratory of Cancer BiologyResearch network
- Collaborators
- Xijing Hospital, Tang-Du Hospital
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 23 Nov 2018 (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.
Colorectal polyps are risk factors for cancer. Early detection of polyps is critical for colorectal cancer management. However, the diagnosis rate of patients with colorectal polyps is still low. Therefore, we design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve diagnosis rate of colorectal polyps.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-endoscopic screening risk assessment | Experimental | Diagnostic Test: pre-endoscopic screening risk assessment |
| routine screening | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65.
- Signed informed consent
Key exclusion criteria (4 listed)
- Severe back ground disease including malignancy.
- State after gastric surgery.
- COPD, CHF, CRF and any disease with respiratory disturbances.
- Deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.
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 |
|---|---|---|
| pre-endoscopic screening risk assessmentpre-endoscopic screening risk assessment | Diagnostic test | pre-endoscopic screening risk assessment |
Primary outcome
Diagnostic rate of patients with polyps
Time frame: 2 year
Diagnostic rate of patients with polyps
1 secondary outcome
Number and characteristics of polyps detected
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-endoscopic screening risk assessment in people with Colorectal Polyp, run by State Key Laboratory of Cancer Biology 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dake Chu, M.D. (86-29-85323922, chudake@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic rate of patients with polyps (time frame: 2 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 23 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.