Colorectal NeoplasmsNCT06791616
Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm
A study testing Colonoscopy in people with Colorectal Neoplasms and Adenoma Colon, run by Asociación Española de Gastroenterología.
Trial summary
Intensive endoscopic surveillance following piecemeal resection of non-pedunculated colorectal lesions (NPCL) ≥20 mm is the current standard of care, given the high recurrence rate of these lesions (15-30%). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Neoplasms, Adenoma Colon, Colonic Polyps
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 746 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 31 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a single non-pedunculated colorectal lesion (NPCL) ≥20 mm that has been resected piecemeal and treated with thermal ablation (using snare tip or argon plasma) at the margins as prophylaxis against recurrence, and who are awaiting the initiation of specific endoscopic follow-up.
- Complete colonoscopy with adequate or excellent bowel preparation performed within the last 6 months prior to the resection of the index lesion.
- Signed informed consent.
Who cannot join
- Resection performed using a cold snare technique due to the high risk of recurrence.
- Histology of the lesion showing malignancy: colorectal cancer with submucosal invasion, regardless of invasion depth in microns.
- Absence of information regarding the grade of dysplasia of the index lesion.
- Personal history of colorectal cancer.
- Incomplete endoscopic resection of the index lesion or any other polyps present in the patient.
- When the endoscopist performing the index colonoscopy expresses doubts about whether the resection was complete.
Show all 12Show fewer
- Index lesion with prior attempted resection.
- Hereditary cancer syndromes (e.g., adenomatous or serrated polyposis syndromes, Lynch syndrome, etc.).
- Inflammatory bowel disease.
- Severe comorbidities with reduced life expectancy.
- Pregnancy.
- Ongoing cytotoxic treatment or radiotherapy for a malignant disease.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm: SCARFACE Clinical Trial
Intensive endoscopic surveillance following piecemeal resection of non-pedunculated colorectal lesions (NPCL) ≥20 mm is the current standard of care, given the high recurrence rate of these lesions (15-30%). However, most recurrences are detected at 12 months, are small and unifocal, and can be easily resected endoscopically. Furthermore, thermal margin ablation has demonstrated a reduction in recurrence rates to 5-6%, highlighting the need to optimize current surveillance protocols, which are costly, invasive, and impose a significant clinical burden.
The multicenter SCARFACE clinical trial aims to evaluate whether a reduced surveillance protocol (at 12 and 48 months) is non-inferior to the standard protocol (at 6, 12, and 48 months) in terms of recurrence rates, using a predefined non-inferiority margin. This non-inferiority design aims to determine if the reduced protocol maintains acceptable efficacy while reducing clinical workload and minimizing risks and discomfort associated with intensive follow-up.
Patients will be randomized in a 1:1 ratio into the two surveillance protocols, with an estimated sample size of 746 lesions. The primary objective is to compare the cumulative incidence of recurrence at 12 months. Secondary objectives include characterizing recurrences, assessing complications associated with endoscopic treatments and evaluating the incidence of advanced colorectal lesions. The findings of this study are expected to directly impact clinical guidelines and routine practice, optimizing resource utilization and improving patient quality of life.
- Conditions
- Colorectal Neoplasms, Adenoma Colon, Colonic Polyps, Serrated Adenoma, Endoscopic Mucosal Resection, Non-pedunculated Lesions
- Being tested
- Colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Surveillance colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Reduced surveillance interval | Experimental | Surveillance colonoscopies at 12 and 48 months Receives: Procedure: Colonoscopy |
| Standard surveillance interval | Placebo comparator | Surveillance colonoscopies at 6, 12 and 48 months Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of recurrence/residual tissue
Measured: 12 months
Secondary outcomes (7)
To compare the cumulative incidence of recurrence/residual tissue
Measured: 48 months
To describe the characteristics of recurrences
Measured: 48 months
To determine the complete endoscopic resection rate in patients who have experienced recurrence.
Measured: 48 months
To analyze the incidence of complications arising from the endoscopic treatment of recurrences.
Measured: 48 months
To determine the proportion of patients requiring surgery to treat recurrence or complications associated with it.
Measured: 48 months
To assess the incidence of advanced colonic lesions or colorectal cancer
Measured: 12 months
To assess the incidence of advanced colonic lesions or colorectal cancer
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 746 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociación Española de Gastroenterología
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Sanitaria y Biomédica de Alicante
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791616
- Sponsor's protocol ID
- SCARFACE
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 24 Jan 2025
- 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surveillance Intervals After Piecemeal Resection of Non-pedunculated Colorectal Lesions ≥20mm: SCARFACE Clinical Trial
- ClinicalTrials.gov ID
- NCT06791616
- Acronym / sponsor ID
- SCARFACE
- Conditions
- Colorectal Neoplasms, Adenoma Colon, Colonic Polyps, Serrated Adenoma, Endoscopic Mucosal Resection, Non-pedunculated Lesions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 746 participants (estimated)
- Lead sponsor
- Asociación Española de GastroenterologíaUniversity, hospital or other
- Collaborators
- Instituto de Investigación Sanitaria y Biomédica de Alicante
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 24 Jan 2025 (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.
Intensive endoscopic surveillance following piecemeal resection of non-pedunculated colorectal lesions (NPCL) ≥20 mm is the current standard of care, given the high recurrence rate of these lesions (15-30%). However, most recurrences are detected at 12 months, are small and unifocal, and can be easily resected endoscopically. Furthermore, thermal margin ablation has demonstrated a reduction in recurrence rates to 5-6%, highlighting the need to optimize current surveillance protocols, which are costly, invasive, and impose a significant clinical burden.
The multicenter SCARFACE clinical trial aims to evaluate whether a reduced surveillance protocol (at 12 and 48 months) is non-inferior to the standard protocol (at 6, 12, and 48 months) in terms of recurrence rates, using a predefined non-inferiority margin. This non-inferiority design aims to determine if the reduced protocol maintains acceptable efficacy while reducing clinical workload and minimizing risks and discomfort associated with intensive follow-up.
Patients will be randomized in a 1:1 ratio into the two surveillance protocols, with an estimated sample size of 746 lesions. The primary objective is to compare the cumulative incidence of recurrence at 12 months. Secondary objectives include characterizing recurrences, assessing complications associated with endoscopic treatments and evaluating the incidence of advanced colorectal lesions. The findings of this study are expected to directly impact clinical guidelines and routine practice, optimizing resource utilization and improving patient quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced surveillance interval | Experimental | Procedure: ColonoscopySurveillance colonoscopies at 12 and 48 months |
| Standard surveillance interval | Placebo comparator | Procedure: ColonoscopySurveillance colonoscopies at 6, 12 and 48 months |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a single non-pedunculated colorectal lesion (NPCL) ≥20 mm that has been resected piecemeal and treated with thermal ablation (using snare tip or argon plasma) at the margins as prophylaxis against recurrence, and who are awaiting the initiation of specific endoscopic follow-up.
- Complete colonoscopy with adequate or excellent bowel preparation performed within the last 6 months prior to the resection of the index lesion.
- Signed informed consent.
Key exclusion criteria (12 listed)
- Resection performed using a cold snare technique due to the high risk of recurrence.
- Histology of the lesion showing malignancy: colorectal cancer with submucosal invasion, regardless of invasion depth in microns.
- Absence of information regarding the grade of dysplasia of the index lesion.
- Personal history of colorectal cancer.
- Incomplete endoscopic resection of the index lesion or any other polyps present in the patient.
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 |
|---|---|---|
| ColonoscopySurveillance colonoscopy | Procedure or surgery | Reduced surveillance interval, Standard surveillance interval |
Primary outcome
Cumulative incidence of recurrence/residual tissue
Time frame: 12 months
7 secondary outcomes
To compare the cumulative incidence of recurrence/residual tissue
Time frame: 48 months
To describe the characteristics of recurrences
Time frame: 48 months
To determine the complete endoscopic resection rate in patients who have experienced recurrence.
Time frame: 48 months
To analyze the incidence of complications arising from the endoscopic treatment of recurrences.
Time frame: 48 months
To determine the proportion of patients requiring surgery to treat recurrence or complications associated with it.
Time frame: 48 months
To assess the incidence of advanced colonic lesions or colorectal cancer
Time frame: 12 months
To assess the incidence of advanced colonic lesions or colorectal cancer
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy in people with Colorectal Neoplasms and Adenoma Colon, run by Asociación Española de Gastroenterología.
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 12 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: opening soon, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Jover, MD, PhD (+34-965913952, rodrigojover@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of recurrence/residual tissue (time frame: 12 months). 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 24 Jan 2025.