Colorectal NeoplasmsCADILLACNCT04673136
Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program.
A study testing GI-GENIUS Medtronic and Colonoscopy in people with Colorectal Neoplasms and Intestinal Neoplasms, run by Asociación Española de Gastroenterología at 6 sites in Spain.
Trial summary
Deep learning technology has an increasing role in medical image applications and, recently, an artificial intelligence device has been developed and commercialized by Medtronic for identification of polyps during colonoscopy (GI-GENIUS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms
- What is being tested?
- GI-GENIUS Medtronic and Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,400 participants
- Where
- 6 sitesSpain
- Study dates
- 1 Apr 2021to 31 Mar 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with a positive result in fecal immunochemical test within the population-based colorectal cancer screening program.
- Complete colonoscopy with cecal intubation.
- Inform consent signed.
Who cannot join
- Personal history of colorectal cancer.
- Family history of colorectal cancer: ≥2 FDR or ≥1 FDR diagnosed before 50 years of age.
- Family history of hereditary colorectal cancer syndromes: Lynch syndrome, FAP, etc.
- Personal history of inflammatory bowel disease.
- Terminal illness.
- Personal history of total proctocolectomy.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Clinic Barcelona
Barcelona
Complexo Hospitalario de Ourense
Ourense
Hospital Universitario Central de Asturias
Oviedo
Hospital Universitario Río Hortega
Valladolid
Hospital Universitario Álvaro Cunqueiro
Vigo
About this study
Official title: Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program. Randomized Controlled Trial.
Deep learning technology has an increasing role in medical image applications and, recently, an artificial intelligence device has been developed and commercialized by Medtronic for identification of polyps during colonoscopy (GI-GENIUS). This kind of computer-aided detection (CADe) devices have demonstrated its ability for improving polyp detection rate (PDR) and the adenoma detection rate (ADR). However, this increase in PDR and ADR is mainly made at the expense of small polyps and non advanced adenomas.
Colonoscopies after a positive fecal immunochemical test (FIT) could be the scenario with a higher prevalence of advanced lesions which could be the ideal situation for demonstrating if these CADe systems are able also to increase the detection of advanced lesions and which kind of advanced lesions are these systems able to detect.
Read more
The CADILLAC study will randomize individuals within the population-based Spanish colorectal cancer screening program to receive a colonoscopy where the endoscopist is assisted by the GI-GENIUS device or to receive a standard colonoscopy.
If our results are positive, that could suppose a big step forward for CADe devices, in terms of definitive demonstration of being of help for efectively identify also advanced lesions.
- Conditions
- Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Colonic Polyp, Colorectal Cancer, Adenoma Colon
- Being tested
- GI-GENIUS Medtronic, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI-GENIUS MedtronicDevice
Colonoscopy assisted by GI-GENIUS device
ColonoscopyOther
Standard colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy assisted by GI-GENIUS | Experimental | Not described Receives: Device: GI-GENIUS Medtronic |
| Standard colonoscopy | Placebo comparator | Not described Receives: Other: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of advanced lesions
To determine the impact of the GI-GENIUS device as an assistant to the endoscopist to detect advanced lesions (advanced adenomas and advanced serrated polyps) in FIT-based screening colonoscopies.
Measured: 15 months
Secondary outcomes (2)
Detection of other type of lesions
To determine the ability of the GI-GENIUS device to detect other lesions (colorectal cancer, adenomas, advanced adenomas, serrated polyps, advanced serrated polyps, non-polypoid lesions ≥10mm and right-sided advanced adenomas)
Measured: 15 months
Characteristics of GI-GENIUS
To describe the characteristics of using the GI-GENIUS device during a colonoscopy: withdrawal time, false-positive and false-negative rate of advanced lesions using the device, etc.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Apr 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies 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
- None (open label)
- Enrolment
- 3,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación Española de Gastroenterología
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673136
- Sponsor's protocol ID
- CADILLAC-01
- Acronym
- CADILLAC
- Status last verified
- Apr 2022
- First submitted
- 13 Dec 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aziz M, Fatima R, Dong C, Lee-Smith W, Nawras A. The impact of deep convolutional neural network-based artificial intelligence on colonoscopy outcomes: A systematic review with meta-analysis. J Gastroenterol Hepatol. 2020 Oct;35(10):1676-1683. doi: 10.1111/jgh.15070. Epub 2020 Apr 26.
PubMed 32267558Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18.
PubMed 29928897Wang P, Berzin TM, Glissen Brown JR, Bharadwaj S, Becq A, Xiao X, Liu P, Li L, Song Y, Zhang D, Li Y, Xu G, Tu M, Liu X. Real-time automatic detection system increases colonoscopic polyp and adenoma detection rates: a prospective randomised controlled study. Gut. 2019 Oct;68(10):1813-1819. doi: 10.1136/gutjnl-2018-317500. Epub 2019 Feb 27.
PubMed 30814121Wang P, Liu X, Berzin TM, Glissen Brown JR, Liu P, Zhou C, Lei L, Li L, Guo Z, Lei S, Xiong F, Wang H, Song Y, Pan Y, Zhou G. Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):343-351. doi: 10.1016/S2468-1253(19)30411-X. Epub 2020 Jan 22.
PubMed 31981517Mangas-Sanjuan C, de-Castro L, Cubiella J, Diez-Redondo P, Suarez A, Pellise M, Fernandez N, Zarraquinos S, Nunez-Rodriguez H, Alvarez-Garcia V, Ortiz O, Sala-Miquel N, Zapater P, Jover R; CADILLAC study investigators. Role of Artificial Intelligence in Colonoscopy Detection of Advanced Neoplasias : A Randomized Trial. Ann Intern Med. 2023 Sep;176(9):1145-1152. doi: 10.7326/M22-2619. Epub 2023 Aug 29.
PubMed 37639723
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program. Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04673136
- Acronym / sponsor ID
- CADILLAC / CADILLAC-01
- Conditions
- Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Colonic Polyp, Colorectal Cancer, Adenoma Colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,400 participants (actual)
- Lead sponsor
- Asociación Española de GastroenterologíaUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 17 Dec 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.
Deep learning technology has an increasing role in medical image applications and, recently, an artificial intelligence device has been developed and commercialized by Medtronic for identification of polyps during colonoscopy (GI-GENIUS). This kind of computer-aided detection (CADe) devices have demonstrated its ability for improving polyp detection rate (PDR) and the adenoma detection rate (ADR). However, this increase in PDR and ADR is mainly made at the expense of small polyps and non advanced adenomas.
Colonoscopies after a positive fecal immunochemical test (FIT) could be the scenario with a higher prevalence of advanced lesions which could be the ideal situation for demonstrating if these CADe systems are able also to increase the detection of advanced lesions and which kind of advanced lesions are these systems able to detect.
The CADILLAC study will randomize individuals within the population-based Spanish colorectal cancer screening program to receive a colonoscopy where the endoscopist is assisted by the GI-GENIUS device or to receive a standard colonoscopy.
If our results are positive, that could suppose a big step forward for CADe devices, in terms of definitive demonstration of being of help for efectively identify also advanced lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy assisted by GI-GENIUS | Experimental | Device: GI-GENIUS Medtronic |
| Standard colonoscopy | Placebo comparator | Other: Colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with a positive result in fecal immunochemical test within the population-based colorectal cancer screening program.
- Complete colonoscopy with cecal intubation.
- Inform consent signed.
Key exclusion criteria (6 listed)
- Personal history of colorectal cancer.
- Family history of colorectal cancer: ≥2 FDR or ≥1 FDR diagnosed before 50 years of age.
- Family history of hereditary colorectal cancer syndromes: Lynch syndrome, FAP, etc.
- Personal history of inflammatory bowel disease.
- Terminal illness.
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 |
|---|---|---|
| GI-GENIUS MedtronicColonoscopy assisted by GI-GENIUS device | Device | Colonoscopy assisted by GI-GENIUS |
| ColonoscopyStandard colonoscopy | Other | Standard colonoscopy |
Primary outcome
Detection of advanced lesions
Time frame: 15 months
To determine the impact of the GI-GENIUS device as an assistant to the endoscopist to detect advanced lesions (advanced adenomas and advanced serrated polyps) in FIT-based screening colonoscopies.
2 secondary outcomes
Detection of other type of lesions
Time frame: 15 months
Characteristics of GI-GENIUS
Time frame: 1 month
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 Apr 2022.
- Results publication: PubMed 32267558Aziz M, Fatima R, Dong C, Lee-Smith W, Nawras A. The impact of deep convolutional neural network-based artificial intelligence on colonoscopy outcomes: A systematic review with meta-analysis. J Gastroenterol Hepatol. 2020 Oct;35(10):1676-1683. doi: 10.1111/jgh.15070. Epub 2020 Apr 26.
- Results publication: PubMed 29928897Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18.
- Results publication: PubMed 30814121Wang P, Berzin TM, Glissen Brown JR, Bharadwaj S, Becq A, Xiao X, Liu P, Li L, Song Y, Zhang D, Li Y, Xu G, Tu M, Liu X. Real-time automatic detection system increases colonoscopic polyp and adenoma detection rates: a prospective randomised controlled study. Gut. 2019 Oct;68(10):1813-1819. doi: 10.1136/gutjnl-2018-317500. Epub 2019 Feb 27.
- Results publication: PubMed 31981517Wang P, Liu X, Berzin TM, Glissen Brown JR, Liu P, Zhou C, Lei L, Li L, Guo Z, Lei S, Xiong F, Wang H, Song Y, Pan Y, Zhou G. Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):343-351. doi: 10.1016/S2468-1253(19)30411-X. Epub 2020 Jan 22.
- Derived from this study: PubMed 37639723Mangas-Sanjuan C, de-Castro L, Cubiella J, Diez-Redondo P, Suarez A, Pellise M, Fernandez N, Zarraquinos S, Nunez-Rodriguez H, Alvarez-Garcia V, Ortiz O, Sala-Miquel N, Zapater P, Jover R; CADILLAC study investigators. Role of Artificial Intelligence in Colonoscopy Detection of Advanced Neoplasias : A Randomized Trial. Ann Intern Med. 2023 Sep;176(9):1145-1152. doi: 10.7326/M22-2619. Epub 2023 Aug 29.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GI-GENIUS Medtronic and Colonoscopy in people with Colorectal Neoplasms and Intestinal Neoplasms, run by Asociación Española de Gastroenterología at 6 sites in Spain.
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 3 inclusion and 6 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 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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. Some participants in this study may receive a placebo. 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?
Detection of advanced lesions (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04673136, which also lists 5 linked publications.
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 Apr 2022.