Digestive System DiseaseNCT03455595
CONECCT (Colorectal Neoplasia Endoscopic Classification To Chose the Endoscopic Treatment)
An observational study of Digestive System Disease, run by Hôpital Edouard Herriot at 1 site in France.
Trial summary
Prospective study so as to evaluate CONECCT score to determine both histological tissue and therapeutic choice Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Digestive System Disease
- What is being tested?
- Endoscopic exams
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2017to 1 Feb 2018
- 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 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Population with colorectal polyps
Who may be able to join
- N/A
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CONECCT Score so as to Improve the Diagnosis and the Treatment of Colorectal Neoplasia
Prospective study so as to evaluate CONECCT score to determine both histological tissue and therapeutic choice
- Conditions
- Digestive System Disease
- Being tested
- Endoscopic exams
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic examsProcedure or surgery
Coloscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the CONECCT endoscopic score so as to improve colon therapeutic treatment polyps
There are recognized diagnostic criteria so as to predict the histology of colorectal lesions and thus to choose the right therapy. For the moment, these criteria are scattered in at least 5 different classifications and the CONECCT tool will allow gastroenterology interns to more easily predict the histology of the lesion and so to improve the management of them.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 Feb 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Edouard Herriot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Christophe Saurin, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455595
- Sponsor's protocol ID
- CONECCT
- Status last verified
- Feb 2018
- First submitted
- 28 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- 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 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONECCT Score so as to Improve the Diagnosis and the Treatment of Colorectal Neoplasia
- ClinicalTrials.gov ID
- NCT03455595
- Acronym / sponsor ID
- CONECCT
- Conditions
- Digestive System Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hôpital Edouard HerriotUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 6 Mar 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.
Prospective study so as to evaluate CONECCT score to determine both histological tissue and therapeutic choice
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Population with colorectal polyps
Key inclusion criteria (1 listed)
- N/A
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Endoscopic examsColoscopy | Procedure or surgery | – |
Primary outcome
Evaluation of the CONECCT endoscopic score so as to improve colon therapeutic treatment polyps
Time frame: one year
There are recognized diagnostic criteria so as to predict the histology of colorectal lesions and thus to choose the right therapy. For the moment, these criteria are scattered in at least 5 different classifications and the CONECCT tool will allow gastroenterology interns to more easily predict the histology of the lesion and so to improve the management of them.
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 12 Mar 2018.
- 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.
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 Digestive System Disease, run by Hôpital Edouard Herriot at 1 site in France.
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 1 inclusion and 1 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 12 Mar 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 France. 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?
Evaluation of the CONECCT endoscopic score so as to improve colon therapeutic treatment polyps (time frame: one 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 12 Mar 2018.