Colorectal CancerNCT05523271
A Multi Center Study Comparing the Efficacy of CAD EYE and the Standard of Care (White Light )
A study testing CAD EYE (Computer Aided Diagnosis ----? in people with Colorectal Cancer, run by Theodor Bilharz Research Institute at 1 site in Egypt.
Trial summary
This study is to assess the sensitivity and added benefits of CADEYE compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- CAD EYE (Computer Aided Diagnosis ----?
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2023to 30 Aug 2023
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-80 years old subjects
- Subjects undergoing colonoscopy for the following: o Primary CRC screening
- Post-polypectomy surveillance
- Work up following FIT positivity
- Symptoms/signs suspicions of CRC
- Subjects must be willing to give written informed consent for the trial
Who cannot join
- Unable to consent
- Contraindicated to undergo endoscopy
- Hospitalized patient
- Patients with the following conditions:
- History of colon resection
- History of CRC
Show all 10Show fewer
- Antithrombotic therapy precluding colon resection o Inflammatory Bowel Disease (IBD)
- Familial Adenomatous Polyposis (FAP)
- Pregnant or lactating
- Poor bowel preparation: BBPS 0 or 1 in a segment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Theodor Bilharz Research Institute
Giza, 12311
Mostafa Ibrahim, MD, 00201006107100, mostafa.ibrahim@webgit.net
Mostafa Ibrahim, MD
About this study
Official title: A Multi-center Control Study to Determine the Efficacy of CADEYE in Detecting Colon Polyps in Comparison to Standard of Care
This study is to assess the sensitivity and added benefits of CADEYE compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.
Read the detailed description
Failure in polyp recognition is a major determinant for the high rate of missed colorectal neoplasms. In response, technological advances have paved the way for Computer-Aided Polyp Detection (CAD-e) systems. Artificial intelligence systems allow of real-time computer- aided detection of polyps with high-accuracy. CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure.
The data generated from this study will provide an estimate of the ADR throughout the Middle East as well as assess the accuracy of CADEYE in detecting adenomas in comparison to standard of care.
- Conditions
- Colorectal Cancer
- Being tested
- CAD EYE (Computer Aided Diagnosis ----?
- Keywords
- Colorectal Cancer screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD EYE (Computer Aided Diagnosis ----?Diagnostic test
CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure and and allows a real time computer aided detection of polyps with high accuracy.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing White Light Endoscopy (standard of care) | No intervention | All subjects in Experimental Arm A will undergo SOC (white-light endoscopy). |
| Patients undergoing CAD EYE endoscopy | Experimental | All subjects in Experimental Arm B will undergo CADEYE endoscopy. Receives: Diagnostic Test: CAD EYE (Computer Aided Diagnosis ----? |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Adenoma detection rate is the primary end point which is the percentage of patients with at least 1 histologically proven adenoma or carcinoma.
Measured: 1 year
Secondary outcomes (4)
Adenomas detected per colonoscopy
Measured: 1 year
Proximal Adenoma detection rate
Measured: 1 year
Withdrawal time
Measured: 1 year
Non-neoplastic detection rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start16 Jan 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
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.
- 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
- Theodor Bilharz Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Ibrahim, Theodor Bilharz Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523271
- Sponsor's protocol ID
- CADEYE
- Status last verified
- Jan 2023
- First submitted
- 29 Aug 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Control Study to Determine the Efficacy of CADEYE in Detecting Colon Polyps in Comparison to Standard of Care
- ClinicalTrials.gov ID
- NCT05523271
- Acronym / sponsor ID
- CADEYE
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Theodor Bilharz Research InstituteUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 31 Aug 2022 (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.
This study is to assess the sensitivity and added benefits of CADEYE compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.
Detailed description
Failure in polyp recognition is a major determinant for the high rate of missed colorectal neoplasms. In response, technological advances have paved the way for Computer-Aided Polyp Detection (CAD-e) systems. Artificial intelligence systems allow of real-time computer- aided detection of polyps with high-accuracy. CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure.
The data generated from this study will provide an estimate of the ADR throughout the Middle East as well as assess the accuracy of CADEYE in detecting adenomas in comparison to standard of care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing White Light Endoscopy (standard of care) | No intervention | –All subjects in Experimental Arm A will undergo SOC (white-light endoscopy). |
| Patients undergoing CAD EYE endoscopy | Experimental | Diagnostic Test: CAD EYE (Computer Aided Diagnosis ----?All subjects in Experimental Arm B will undergo CADEYE endoscopy. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 40-80 years old subjects
- Subjects undergoing colonoscopy for the following: o Primary CRC screening
- Subjects must be willing to give written informed consent for the trial
Key exclusion criteria (10 listed)
- Unable to consent
- Contraindicated to undergo endoscopy
- Hospitalized patient
- Patients with the following conditions:
- Pregnant or lactating
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 |
|---|---|---|
| CAD EYE (Computer Aided Diagnosis ----?CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure and and allows a real time computer aided detection of polyps with high accuracy. | Diagnostic test | Patients undergoing CAD EYE endoscopy |
Primary outcome
Adenoma detection rate
Time frame: 1 year
Adenoma detection rate is the primary end point which is the percentage of patients with at least 1 histologically proven adenoma or carcinoma.
4 secondary outcomes
Adenomas detected per colonoscopy
Time frame: 1 year
Proximal Adenoma detection rate
Time frame: 1 year
Withdrawal time
Time frame: 1 year
Non-neoplastic detection rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD EYE (Computer Aided Diagnosis ----? in people with Colorectal Cancer, run by Theodor Bilharz Research Institute at 1 site in Egypt.
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 6 inclusion and 10 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 19 Jan 2023. 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 Egypt. 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 Mostafa Ibrahim, M.D PhD (01006107100, mostafa.ibrahim@webgit.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 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 19 Jan 2023.