An interventional study of Colonoscopy in Colorectal Neoplasms, Adenoma Colon and Colonic Polyps, sponsored by Asociación Española de Gastroenterología. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by Asociación Española de Gastroenterología · Not applicable, Interventional, and Other
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 746 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Asociación Española de Gastroenterología is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surveillance colonoscopies at 12 and 48 months
Procedure: Colonoscopy
Surveillance colonoscopies at 6, 12 and 48 months
Procedure: Colonoscopy
Surveillance colonoscopy
Cumulative incidence of recurrence/residual tissue
Time frame: 12 months
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for May 2027, 26 months later.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 26 months is below that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Asociación Española de Gastroenterología