Superficial Colorectal TumorsRECNCT03470883
Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors
An observational study of Superficial Colorectal Tumors, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
To evaluate the long-term complete remission rate (> 12 months) after endoscopic treatment of early neoplastic colorectal lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Colorectal Tumors
- What is being tested?
- Evaluation of the long-term complete remission rate (> 12 months)
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2012to 2 Nov 2017
- 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: Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification
Who may be able to join
- Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification during the last 5 years at the institute.
Who cannot join
- Adenomas with low grade dysplasia
- Endoscopic control not available
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the long-term complete remission rate (> 12 months) after endoscopic treatment of early neoplastic colorectal lesions.
Read the detailed description
Intra-mucous colorectal neoplasia lesions (or even with minimal mucosal infiltration), formerly treated surgically, are increasingly treated endoscopically.
The IPC as a center for interventional endoscopy has been taking care of these lesions for several years.
Resection techniques have diversified since the 2000s (polypectomy, monobloc or piecemeal mucosectomy, submucosal dissection ... etc) and the endoscopy team has developed its various techniques within the institute ; Practice has evolved and has not been studied or evaluated in recent years. The purpose of this study is to evaluate practices and to compare results with the literature, and to identify predictive factors for the failure or success of endoscopic treatment of these early neoplastic lesions.
- Conditions
- Superficial Colorectal Tumors
- Being tested
- Evaluation of the long-term complete remission rate (> 12 months)
- Keywords
- endoscopic resection, colorectal adenomas, Colorectal adenocarcinomas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the long-term complete remission rate (> 12 months)Other
Evaluation of the long-term complete remission rate (> 12 months)
| Study group | Role | What they receive |
|---|---|---|
| endoscopic resection of a colorectal lesion | Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification during the last 5 years at the institute. Receives: Other: Evaluation of the long-term complete remission rate (> 12 months) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete long-term remission (> 12 months)
Evaluation of the long-term complete remission rate (> 12 months)
Measured: 13 months
Secondary outcomes (6)
Absence of residual lesion on early control (3 to 6 months)
Medium-term response rate (3 to 6 months)
Measured: 3 to 6 months
Rates of medium and long-term recurrence
Recurrence rate in the medium and long term
Measured: 13 months
Management of medium and long-term recurrence
Management of recurrence (endoscopic revision or surgery)
Measured: 13 months
Morbidity and mortality rates
Morbidity and mortality rate of endoscopic resection
Measured: 13 months
Lymph node or visceral metastatic evolution rate
Rate of pejorative lymph node or metastatic evolution (especially for lesions with microinfiltration of the submucosa)
Measured: 13 months
Endoscopic description and anatomopathological results
Endoscopic and / or anatomopathological predictive factors of success (complete long-term remission)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Jan 2012
- Primary completion31 Dec 2016
- Study completion2 Nov 2017
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 Superficial Colorectal TumorsStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe RATONE, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470883
- Sponsor's protocol ID
- REC-IPC 2017-035
- Acronym
- REC
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dixon MF. Gastrointestinal epithelial neoplasia: Vienna revisited. Gut. 2002 Jul;51(1):130-1. doi: 10.1136/gut.51.1.130.
PubMed 12077106Repici A, Pellicano R, Strangio G, Danese S, Fagoonee S, Malesci A. Endoscopic mucosal resection for early colorectal neoplasia: pathologic basis, procedures, and outcomes. Dis Colon Rectum. 2009 Aug;52(8):1502-15. doi: 10.1007/DCR.0b013e3181a74d9b.
PubMed 19617768Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.
PubMed 24986245Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.
PubMed 28212588Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.
PubMed 24671869
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors
- ClinicalTrials.gov ID
- NCT03470883
- Acronym / sponsor ID
- REC / REC-IPC 2017-035
- Conditions
- Superficial Colorectal Tumors
- Keywords
- endoscopic resection, colorectal adenomas, Colorectal adenocarcinomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 20 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.
To evaluate the long-term complete remission rate (> 12 months) after endoscopic treatment of early neoplastic colorectal lesions.
Detailed description
Intra-mucous colorectal neoplasia lesions (or even with minimal mucosal infiltration), formerly treated surgically, are increasingly treated endoscopically.
The IPC as a center for interventional endoscopy has been taking care of these lesions for several years.
Resection techniques have diversified since the 2000s (polypectomy, monobloc or piecemeal mucosectomy, submucosal dissection ... etc) and the endoscopy team has developed its various techniques within the institute ; Practice has evolved and has not been studied or evaluated in recent years. The purpose of this study is to evaluate practices and to compare results with the literature, and to identify predictive factors for the failure or success of endoscopic treatment of these early neoplastic lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endoscopic resection of a colorectal lesion | – | Other: Evaluation of the long-term complete remission rate (> 12 months)Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification during the last 5 years at the institute. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification
Key inclusion criteria (1 listed)
- Patient having undergone endoscopic resection of a colorectal lesion stage 4 or 5 of the modified Vienna classification during the last 5 years at the institute.
Key exclusion criteria (2 listed)
- Adenomas with low grade dysplasia
- Endoscopic control not available
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 |
|---|---|---|
| Evaluation of the long-term complete remission rate (> 12 months)Evaluation of the long-term complete remission rate (> 12 months) | Other | endoscopic resection of a colorectal lesion |
Primary outcome
Complete long-term remission (> 12 months)
Time frame: 13 months
Evaluation of the long-term complete remission rate (> 12 months)
6 secondary outcomes
Absence of residual lesion on early control (3 to 6 months)
Time frame: 3 to 6 months
Rates of medium and long-term recurrence
Time frame: 13 months
Management of medium and long-term recurrence
Time frame: 13 months
Morbidity and mortality rates
Time frame: 13 months
Lymph node or visceral metastatic evolution rate
Time frame: 13 months
Endoscopic description and anatomopathological results
Time frame: 1 day
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 24 May 2018.
- Background: PubMed 12077106Dixon MF. Gastrointestinal epithelial neoplasia: Vienna revisited. Gut. 2002 Jul;51(1):130-1. doi: 10.1136/gut.51.1.130.
- Background: PubMed 19617768Repici A, Pellicano R, Strangio G, Danese S, Fagoonee S, Malesci A. Endoscopic mucosal resection for early colorectal neoplasia: pathologic basis, procedures, and outcomes. Dis Colon Rectum. 2009 Aug;52(8):1502-15. doi: 10.1007/DCR.0b013e3181a74d9b.
- Background: PubMed 24986245Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.
- Results publication: PubMed 28212588Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.
- Results publication: PubMed 24671869Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.
- 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.
Jean-Philippe RATONE principal investigator
Institut Paoli-Calmettes
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 Superficial Colorectal Tumors, run by Institut Paoli-Calmettes 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 2 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 24 May 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?
Complete long-term remission (> 12 months) (time frame: 13 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 NCT03470883, 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 24 May 2018.