Colorectal Cancerpro-CONECCTNCT05983315
Prospective Assessment of CONECCT's Classification for Colorectal Lesions.
An observational study of Colorectal Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Colorectal neoplastic lesion endoscopic characterization is a key element for histological predictive diagnostic value in conducting best appropriate resection choice. Six classifications are necessary for fully correct characterization of different colorectal lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 750 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 1 Nov 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every patient who needs diagnostic colonoscopy because of digestive symptoms, medical or family history of colorectal cancer/polyps, positive colorectal screening test, acromegaly or referred by another gastroenterologist upon discovery of colorectal polyp after colonoscopy can join the cohort of this study.
Who may be able to join
- both gender patients even or older than 18 years old
- patient in need of proven diagnostic or therapeutic colonoscopy for colorectal lesion resection
- patient with French Health Insurance coverage
- obtaining of oral non opposition to research after loyal, clear and complete delivery of information
Who cannot join
- previous attempt of lesion resection by mucosectomy
- patient with a metastatic lesion diagnosed prior to colonoscopy
- patient with no colorectal lesion
- adenomatous or sessile serrated polyposis syndrome
- patient with bowel chronic inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Assessment of CONECCT's Classification for Histological Predictive Diagnostic Value in Conducting Therapeutic Choice for Colorectal Lesions. Pro-CONECCT
Colorectal neoplastic lesion endoscopic characterization is a key element for histological predictive diagnostic value in conducting best appropriate resection choice. Six classifications are necessary for fully correct characterization of different colorectal lesions. Nonetheless, it can be tricky to use so many diagnostic tools with so many subcategories in the 6 existing classifications. That's why we decided to integrate all 6 existing classification validated factors in one single chart (CONECCT chart) allowing to both predict histological diagnostic value and to propose the best appropriate resection strategy. A previous prospective and multicentre study with all French medical residents in gastroenterology was conducted in order to prove pedagogic interest of this diagnostic tool. Each student was asked to review 20 files with lesion pictures before and after lecture about CONECCT chart. This allowed us to prove that this diagnostic tool could significantly improve both histological predictive diagnostic value and therapeutic choice by French medical residents and gastroenterologists. Our hypothesis is that CONECCT's classification can improve predictive diagnostic value of colorectal lesions in over 80% of cases. Now that pedagogic interest of this diagnostic tool has been proven, we would like to carry out a larger prospective assessment in term of performance (value) of this instrument in order to both facilitate endoscopic characterization and allow a most appropriate diagnostic and therapeutic management of each colorectal lesion category.
- Conditions
- Colorectal Cancer
- Keywords
- diagnostic tool, colorectal cancer, therapeutic choice guidance, CONECCT
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CONECCT's classification assessment | Every patient who needs diagnostic colonoscopy because of digestive symptoms, medical or family history of colorectal cancer/polyps, positive colorectal screening test, acromegaly or referred by another gastroenterologist upon discovery of colorectal polyp after colonoscopy can join the cohort of this study and can get CONECCT's classification histological assessment of their neoplastic lesion by experienced endoscopist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between endoscopic CONECCT's classification
assessed by one of research site operators and final histology reading of neoplastic lesion by anatomopathologist:
- CONECCT 0E : neuroendocrine tumor
- CONECCT IH : hyperplastic polyp
- CONECCT IS : sessile serrated lesion with or without dysplasia
- CONECCT IIA : low or high grade adenoma
- CONECCT IIC : low or high grade adenoma or intramucosal or submucosal <1000 micron adenocarcinoma
- CONECCT III : deep invasive submucosal > 1000 microns adenocarcinoma
Measured: Time point can be reached either 2 weeks after endoscopic resection at V1 or between 2-4 months later in case of surgery at V3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Jul 2021
- Primary completion1 Jul 2022
- Study completion1 Nov 2022
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 Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983315
- Sponsor's protocol ID
- 69HCL21_0780
- Acronym
- pro-CONECCT
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of CONECCT's Classification for Histological Predictive Diagnostic Value in Conducting Therapeutic Choice for Colorectal Lesions. Pro-CONECCT
- ClinicalTrials.gov ID
- NCT05983315
- Acronym / sponsor ID
- pro-CONECCT / 69HCL21_0780
- Conditions
- Colorectal Cancer
- Keywords
- diagnostic tool, colorectal cancer, therapeutic choice guidance, CONECCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 9 Aug 2023 (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 neoplastic lesion endoscopic characterization is a key element for histological predictive diagnostic value in conducting best appropriate resection choice. Six classifications are necessary for fully correct characterization of different colorectal lesions. Nonetheless, it can be tricky to use so many diagnostic tools with so many subcategories in the 6 existing classifications. That's why we decided to integrate all 6 existing classification validated factors in one single chart (CONECCT chart) allowing to both predict histological diagnostic value and to propose the best appropriate resection strategy. A previous prospective and multicentre study with all French medical residents in gastroenterology was conducted in order to prove pedagogic interest of this diagnostic tool. Each student was asked to review 20 files with lesion pictures before and after lecture about CONECCT chart. This allowed us to prove that this diagnostic tool could significantly improve both histological predictive diagnostic value and therapeutic choice by French medical residents and gastroenterologists. Our hypothesis is that CONECCT's classification can improve predictive diagnostic value of colorectal lesions in over 80% of cases. Now that pedagogic interest of this diagnostic tool has been proven, we would like to carry out a larger prospective assessment in term of performance (value) of this instrument in order to both facilitate endoscopic characterization and allow a most appropriate diagnostic and therapeutic management of each colorectal lesion category.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CONECCT's classification assessment | – | –Every patient who needs diagnostic colonoscopy because of digestive symptoms, medical or family history of colorectal cancer/polyps, positive colorectal screening test, acromegaly or referred by another gastroenterologist upon discovery of colorectal polyp after colonoscopy can join the cohort of this study and can get CONECCT's classification histological assessment of their neoplastic lesion by experienced endoscopist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient who needs diagnostic colonoscopy because of digestive symptoms, medical or family history of colorectal cancer/polyps, positive colorectal screening test, acromegaly or referred by another gastroenterologist upon discovery of colorectal polyp after colonoscopy can join the cohort of this study.
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between endoscopic CONECCT's classification
Time frame: Time point can be reached either 2 weeks after endoscopic resection at V1 or between 2-4 months later in case of surgery at V3
assessed by one of research site operators and final histology reading of neoplastic lesion by anatomopathologist: * CONECCT 0E : neuroendocrine tumor * CONECCT IH : hyperplastic polyp * CONECCT IS : sessile serrated lesion with or without dysplasia * CONECCT IIA : low or high grade adenoma * CONECCT IIC : low or high grade adenoma or intramucosal or submucosal <1000 micron adenocarcinoma * CONECCT III : deep invasive submucosal > 1000 microns adenocarcinoma
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 9 Aug 2023.
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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 Colorectal Cancer, run by Hospices Civils de Lyon 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 4 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 9 Aug 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 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?
Correlation between endoscopic CONECCT's classification (time frame: Time point can be reached either 2 weeks after endoscopic resection at V1 or between 2-4 months later in case of surgery at V3). 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 9 Aug 2023.