Colorectal CancerNCT02231385
Acetic Acid Colonoscopy Enhancement Study
A study testing Acetic Acid in people with Colorectal Cancer and Serrated Adenomas, run by Istituto Clinico Humanitas at 2 sites in Italy.
Trial summary
The purpose of this study is to compare the additional diagnostic yield obtained by using the acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Cancer, Serrated Adenomas, Colon Nos Polypectomy Tubular Adenoma
- What is being tested?
- Acetic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesItaly
- Study dates
- Sep 2014to Jun 2015
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is >40 years old
- The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- The patient must understand and provide written consent for the procedure.
Who cannot join
- Patients with a history of colonic resection;
- Patients with inflammatory bowel disease;
- Patients with a personal history of polyposis syndrome;
- Patients with suspected chronic stricture potentially precluding complete colonoscopy;
- Patients with diverticulitis or toxic megacolon;
- Patients with a history of radiation therapy to abdomen or pelvis;
- Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Nuovo Regina Margherita Hospital
Rome, 00153
Cesare Hassan, MD, +3906 77301, cesareh@hotmail.com
Cesare Hassan, MD
Humanitas Research Hospital
Rozzano, Milan, 20089
Alessandro Repici, MD, +390282247493, alessandro.repici@humanitas.it
Alessandro Repici, MD
About this study
The purpose of this study is to compare the additional diagnostic yield obtained by using the acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy.
Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures limited to the examination of the right colon.
Read more
Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.
Results from the two groups will be analyzed and compared, with primary outcome measures being detection rates for serrated lesions. Secondary outcome measures will include adenoma detection rate in the right colon or other locations, characteristics of polyps detected, including size and histological results.
Subjects will be followed through a 24-72 hour telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.
- Being tested
- Acetic Acid
- Keywords
- Colorectal cancer, Serrated adenomas, Screening, Adenoma detection rate, Polypectomy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetic AcidDrug
Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes.
Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.
| Study group | Role | What they receive |
|---|---|---|
| Acetic Acid | Experimental | Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes.
Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time. Receives: Drug: Acetic Acid |
| Control Group | No intervention | Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Additional serrated lesions diagnosed after acetic acid spraying
Primary outcome is the additional number of serrated lesions detected at the level of the right colon after spraying of acetic acid and compared with the number of the same lesions detected after a second examination of the right colon using standard white-light high definition scopes
Measured: 12 months
Secondary outcomes (4)
- Number of new adenoma detected at second right colon examination in both studies group
Measured: 12 months
Number of overall serrated and/or adenomatous lesions in the whole colon
Measured: 12 months
Characteristic of lesions detected (size, morphology)
Measured: 12 months
Complication rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015 (estimated)
- Study completionJun 2015 (estimated)
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Nuovo Regina Margherita Hospital
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Alessandro Repici, MD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-MilanCesare Hassan, MD, Principal investigator, Nuovo Regina Margherita Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231385
- Sponsor's protocol ID
- The "ACE" Study
- Status last verified
- Sep 2014
- First submitted
- 1 Sep 2014
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetic Acid Colonoscopy Enhancement Study
- ClinicalTrials.gov ID
- NCT02231385
- Acronym / sponsor ID
- The "ACE" Study
- Keywords
- Colorectal cancer, Serrated adenomas, Screening, Adenoma detection rate, Polypectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Nuovo Regina Margherita Hospital
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 4 Sep 2014 (estimated)
- 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.
The purpose of this study is to compare the additional diagnostic yield obtained by using the acetic acid as vital substance to improve the detection of serrated lesions at colonoscopy.
Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures limited to the examination of the right colon.
Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time.
Results from the two groups will be analyzed and compared, with primary outcome measures being detection rates for serrated lesions. Secondary outcome measures will include adenoma detection rate in the right colon or other locations, characteristics of polyps detected, including size and histological results.
Subjects will be followed through a 24-72 hour telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetic Acid | Experimental | Drug: Acetic AcidSubjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time. |
| Control Group | No intervention | –Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient is >40 years old
- The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- The patient must understand and provide written consent for the procedure.
Key exclusion criteria (7 listed)
- Patients with a history of colonic resection;
- Patients with inflammatory bowel disease;
- Patients with a personal history of polyposis syndrome;
- Patients with suspected chronic stricture potentially precluding complete colonoscopy;
- Patients with diverticulitis or toxic megacolon;
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 |
|---|---|---|
| Acetic AcidSubjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes. Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time. | Drug | Acetic Acid |
Primary outcome
Additional serrated lesions diagnosed after acetic acid spraying
Time frame: 12 months
Primary outcome is the additional number of serrated lesions detected at the level of the right colon after spraying of acetic acid and compared with the number of the same lesions detected after a second examination of the right colon using standard white-light high definition scopes
4 secondary outcomes
- Number of new adenoma detected at second right colon examination in both studies group
Time frame: 12 months
Number of overall serrated and/or adenomatous lesions in the whole colon
Time frame: 12 months
Characteristic of lesions detected (size, morphology)
Time frame: 12 months
Complication rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.
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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.
Alessandro Repici, MD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
Cesare Hassan, MD principal investigator
Nuovo Regina Margherita Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetic Acid in people with Colorectal Cancer and Serrated Adenomas, run by Istituto Clinico Humanitas at 2 sites in Italy.
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 7 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: status not confirmed, as of the sponsor's last update on 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Repici, MD (+390282247493, alessandro.repici@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Additional serrated lesions diagnosed after acetic acid spraying (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 4 Sep 2014; AzTrials last refreshed its copy on 28 Oct 2026.