Polyp ColorectalFILLIPNCT06220149
Post Polypectomy Bleeding. Que Sera, Sera? Whatever Will be, Will be?
An observational study of Polyp Colorectal and Bleeding, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Patients with colorectal polyps removed endoscopically (polypectomy, endoscopic mucosal resection, underwater endoscopic mucosal resection, endoscopic submucosal dissection) may experience delayed post polypectomy bleeding. The incidence is about one in 40 cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyp Colorectal, Bleeding
- What is being tested?
- FIT (fecal immunochemical test)
- How many people
- 200 participants
- Where
- 1 siteRomania
- Study dates
- 6 May 2024to Dec 2025
- 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 above 18 years old with the indication of colonoscopy, satisfying inclusion and exclusion criteria.
Who may be able to join
- Patient with at least one advanced adenoma > 10mm diameter resected at colonoscopy by polypectomy, EMR, underwater EMR or ESD
- Age > 18 years old
- Written informed consent.
Who cannot join
- Synchronous advanced colorectal cancer
- Synchronous unresected advanced adenomas
- Concomitant inflammatory bowel disease or any active colitis
- Absence of written informed consent
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
"Agrippa Ionescu" Hospital
Bucharest
Mihai L Ciocirlan, 0040722322625, mihai.ciocirlan@umfcd.ro
About this study
Official title: FIT for Post poLypectomy bLeeding Prediction
Patients with colorectal polyps removed endoscopically (polypectomy, endoscopic mucosal resection, underwater endoscopic mucosal resection, endoscopic submucosal dissection) may experience delayed post polypectomy bleeding. The incidence is about one in 40 cases.
There are risks factors for this complication, depending on the polyp type, patient demographics and co-morbidities and polypectomy technique. There are meta-analysis and nomograms for risk prediction available.
We will try to predict delayed post polypectomy bleeding by using FIT (fecal immunochemical test), with a cut-off adapted to detect post polypectomy bleeding, administered daily for 2 weeks after polypectomy.
Read the detailed description
Why should one be concerned about delayed post polypectomy bleeding (DPPB)? One in 40 patients with polypectomy for large polyps will have it. A large systematic review of 50 studies including 6779 large polyps > 20mm resected by polypectomy, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), "en bloc" or in piece-meal have had an DPPB incidence of 2.6% (2.1% - 3.2%) [1].
Cand we generally predict what group of patients are more likely to have DPPB? Jaruvongvanich et al [2] have designed a meta-analysis of 12 studies on 14,313 patients. The pooled DPPB rate was 1.5% (0.7% - 3.4%). Cardiovascular disease (OR = 1.55), hypertension (OR = 1.53), polyp size > 10 mm (OR = 3.41), and polyps located in the right colon (OR = 1.60) were identified as significant DPPB risk factors, whereas age, sex, alcohol use, smoking, diabetes, cerebrovascular disease, pedunculated morphology, and carcinoma histology were not.
Huai et al [3] have designed a nomogram for DPPB prediction, based on 6 parameters, with a high AUC of 0.824 in the validation model, as in Figure 1, below. The model states that older men on anticoagulant, with pedunculated polyps on the right side are likely to bleed more often. Age, gender, and pedunculated morphology were included in the model, as risk factors, as opposed to previously mentioned paper [2]. The jury is probably still out for certain risk factors.
Yet, at the individual level, what could a patient do? Could a form of active surveillance for DPPB may be proposed?
Here's an idea. Fecal Immunochemical Test (FIT). FIT can detect minute quantities of hemoglobin in faces. It is used for colorectal cancer population screening in asymptomatic average risk individuals (eg. 50 to 75 years old) or in primary care in certain groups of symptomatic individuals, without overt rectal bleeding, as an adjunct decision tool for colonoscopy evaluation [5]. A recent meta-analysis on more than 6 million asymptomatic average risk individuals of which more than 2.6 million completed a screening FIT test have found a 5.4% positivity rate, an 85% colonoscopy completion rate, a 47.8% adenoma detection rate, a 25.3% advanced adenoma detection rate and a 5.1% colorectal cancer rate [6].
The fecal hemoglobin (f-Hb) cut-offs are set at 10 or 20 microg/g feces in majority of screening programs, depending on colorectal cancer incidence and the healthcare system's colonoscopy availability [7]. FIT result is usually read in central laboratory by specialized machines with cut-off threshold set by the health policy makers.
Mowat et al [8] have used FIT tests differently. They studied the dynamic of FIT values, before and after colonoscopy with polypectomy. They have found that the median pre-polypectomy f-Hb was significantly greater in advanced adenomas as compared to non-advanced adenomas (6.0 vs. 1.0 μg/g feces, p < 0.0001). For patients with both pre and post polypectomy FIT, the dynamic showed a significant decrease for advanced adenomas (19.2 microg/g pre-polypectomy decreasing to 3.5 microg/g post-polypectomy, p=0.01) and remained fairly constant and low for non-advanced adenomas (0.8 microg/g pre-polypectomy to 1.0 microg/g post-polypectomy, p = 0.96). To note that the authors recommended patients that the second FIT test be taken after 3-weeks to allow healing of colorectal resection site, an interval arbitrarily chosen based on experience. This would theoretically avoid false positive elevated quantitative FIT test values due to occult bleeding form the resection site.
Maybe we can use FIT for DPPB surveillance. There are, however, few obstacles:
- The time to epithelization of a resection site is unknown, possibly 3-weeks as Mowat et al [8] have assumed. It depends on lesion size and whether the resection site has been closed with metallic clips.
- The occult bleeding from the resection site depends on time to epithelization, the prophylactic coagulation of vessels at the end of the procedure (snare tip, APC, CoagGrasper), the use of hemostatic gel (Purastat).
- The probability of positive FIT depends on the occult bleeding from the resection site, location (rectum versus right colon) and FIT cut-off value.
- FIT laboratory central reading for quantitative tests takes a certain amount of time (post office time) which defies the purpose of a rapid result for an immediate individual predictive information.
- DPPB mostly occurs in the first week after polypectomy and extremely rarely in the second week after polypectomy [4].
There are a lot of known unknowns and unknown unknowns.
We propose to use a rapid qualitative FIT test to be self-administered daily by the patient in the first 2 weeks after colonoscopy, after each passage of feces.
This will hopefully identify a desirable dynamic pattern of FIT results:
- Positive daily until day X, negative afterwards
- Positive daily until day X, negative afterwards, but then again positive in day Y just before DPPB We could hypothetically, do a rapid test in the day Y and if negative maybe leave the patient go about his usual activities, hobbies, and holidays.
The proposed qualitative rapid FIT is HEMOTRUST (Biosyntex, Switzerland, www.biosyntex.com). The cut-off for HEMOTRUST is 6 microg/g, which is lower than advanced adenoma pre-polypectomy values and higher than post-polypectomy values for both advanced and non-advanced adenomas [8].
Aim of the research project We aim to study the DPPB predictive value of FIT after resection of advanced colorectal adenomas.
Question of the research project Is there a dynamic of f-Hb presence after resection of advanced adenomas? Is this dynamic different in patients with DPPB after resection of advanced adenomas? Could we predict DPPB by studying f-Hb dynamic using qualitative rapid FIT?
Hypothesis The f-Hb assessment dynamic using qualitative rapid FIT may help predict DPPB at the individual level.
- Conditions
- Polyp Colorectal, Bleeding
- Being tested
- FIT (fecal immunochemical test)
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT (fecal immunochemical test)Diagnostic test
A FIT (fecal immunochemical test) will be done daily for the 14 days following polypectomy.
| Study group | Role | What they receive |
|---|---|---|
| Post polypectomy cohort | Not described Receives: Diagnostic Test: FIT (fecal immunochemical test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day of maximum probability of positive FIT to detect delayed post polypectomy bleeding
Day (1 - 14) of positive FIT with maximum 24h before delayed post polypectomy bleeding
Measured: 14 days
Secondary outcomes (2)
Time to delayed post polypectomy bleeding
Duration to delayed post polypectomy bleeding
Measured: 14 days
Time of FIT positivity after polypectomy with no delayed post polypectomy bleeding
Duration of FIT positivity after polypectomy with no delayed post polypectomy bleeding
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start6 May 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Polyp ColorectalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihai Ciocirlan, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220149
- Sponsor's protocol ID
- FILLIP
- Acronym
- FILLIP
- Status last verified
- May 2024
- First submitted
- 9 Jan 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hassan C, Repici A, Sharma P, Correale L, Zullo A, Bretthauer M, Senore C, Spada C, Bellisario C, Bhandari P, Rex DK. Efficacy and safety of endoscopic resection of large colorectal polyps: a systematic review and meta-analysis. Gut. 2016 May;65(5):806-20. doi: 10.1136/gutjnl-2014-308481. Epub 2015 Feb 13.
PubMed 25681402Jaruvongvanich V, Prasitlumkum N, Assavapongpaiboon B, Suchartlikitwong S, Sanguankeo A, Upala S. Risk factors for delayed colonic post-polypectomy bleeding: a systematic review and meta-analysis. Int J Colorectal Dis. 2017 Oct;32(10):1399-1406. doi: 10.1007/s00384-017-2870-0. Epub 2017 Aug 5.
PubMed 28779355Huai J, Ye X, Ding J. Nomogram for the Prediction of Delayed Colorectal Post-Polypectomy Bleeding. Turk J Gastroenterol. 2021 Sep;32(9):727-734. doi: 10.5152/tjg.2021.20842.
PubMed 34609301Lu Y, Zhou X, Chen H, Ding C, Si X. Establishment of a model for predicting delayed post-polypectomy bleeding: A real-world retrospective study. Front Med (Lausanne). 2022 Oct 19;9:1035646. doi: 10.3389/fmed.2022.1035646. eCollection 2022.
PubMed 36341244Monahan KJ, Davies MM, Abulafi M, Banerjea A, Nicholson BD, Arasaradnam R, Barker N, Benton S, Booth R, Burling D, Carten RV, D'Souza N, East JE, Kleijnen J, Machesney M, Pettman M, Pipe J, Saker L, Sharp L, Stephenson J, Steele RJ. Faecal immunochemical testing (FIT) in patients with signs or symptoms of suspected colorectal cancer (CRC): a joint guideline from the Association of Coloproctology of Great Britain and Ireland (ACPGBI) and the British Society of Gastroenterology (BSG). Gut. 2022 Jul 12;71(10):1939-62. doi: 10.1136/gutjnl-2022-327985. Online ahead of print.
PubMed 35820780Mohan BP, Khan SR, Daugherty E, Chandan S, Ponnada S, Facciorusso A, Kassab LL, Asokkumar R, Adler DG. Pooled rates of adenoma detection by colonoscopy in asymptomatic average-risk individuals with positive fecal immunochemical test: a systematic review and meta-analysis. Gastrointest Endosc. 2022 Aug;96(2):208-222.e14. doi: 10.1016/j.gie.2022.04.004. Epub 2022 Apr 9.
PubMed 35413330Pokharel R, Lin YS, McFerran E, O'Mahony JF. A Systematic Review of Cost-Effectiveness Analyses of Colorectal Cancer Screening in Europe: Have Studies Included Optimal Screening Intensities? Appl Health Econ Health Policy. 2023 Sep;21(5):701-717. doi: 10.1007/s40258-023-00819-3. Epub 2023 Jun 28.
PubMed 37380865Mowat C, Digby J, Cleary S, Gray L, Datt P, Goudie DR, Steele RJ, Strachan JA, Humphries A, Fraser CG. Faecal haemoglobin concentration in adenoma, before and after polypectomy, approaches the ideal tumour marker. Ann Clin Biochem. 2022 Jul;59(4):272-276. doi: 10.1177/00045632221080897. Epub 2022 Mar 2.
PubMed 35235491
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIT for Post poLypectomy bLeeding Prediction
- ClinicalTrials.gov ID
- NCT06220149
- Acronym / sponsor ID
- FILLIP / FILLIP
- Conditions
- Polyp Colorectal, Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jan 2024 (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.
Patients with colorectal polyps removed endoscopically (polypectomy, endoscopic mucosal resection, underwater endoscopic mucosal resection, endoscopic submucosal dissection) may experience delayed post polypectomy bleeding. The incidence is about one in 40 cases.
There are risks factors for this complication, depending on the polyp type, patient demographics and co-morbidities and polypectomy technique. There are meta-analysis and nomograms for risk prediction available.
We will try to predict delayed post polypectomy bleeding by using FIT (fecal immunochemical test), with a cut-off adapted to detect post polypectomy bleeding, administered daily for 2 weeks after polypectomy.
Detailed description
Why should one be concerned about delayed post polypectomy bleeding (DPPB)? One in 40 patients with polypectomy for large polyps will have it. A large systematic review of 50 studies including 6779 large polyps > 20mm resected by polypectomy, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), "en bloc" or in piece-meal have had an DPPB incidence of 2.6% (2.1% - 3.2%) [1].
Cand we generally predict what group of patients are more likely to have DPPB? Jaruvongvanich et al [2] have designed a meta-analysis of 12 studies on 14,313 patients. The pooled DPPB rate was 1.5% (0.7% - 3.4%). Cardiovascular disease (OR = 1.55), hypertension (OR = 1.53), polyp size > 10 mm (OR = 3.41), and polyps located in the right colon (OR = 1.60) were identified as significant DPPB risk factors, whereas age, sex, alcohol use, smoking, diabetes, cerebrovascular disease, pedunculated morphology, and carcinoma histology were not.
Huai et al [3] have designed a nomogram for DPPB prediction, based on 6 parameters, with a high AUC of 0.824 in the validation model, as in Figure 1, below. The model states that older men on anticoagulant, with pedunculated polyps on the right side are likely to bleed more often. Age, gender, and pedunculated morphology were included in the model, as risk factors, as opposed to previously mentioned paper [2]. The jury is probably still out for certain risk factors.
Yet, at the individual level, what could a patient do? Could a form of active surveillance for DPPB may be proposed?
Here's an idea. Fecal Immunochemical Test (FIT). FIT can detect minute quantities of hemoglobin in faces. It is used for colorectal cancer population screening in asymptomatic average risk individuals (eg. 50 to 75 years old) or in primary care in certain groups of symptomatic individuals, without overt rectal bleeding, as an adjunct decision tool for colonoscopy evaluation [5]. A recent meta-analysis on more than 6 million asymptomatic average risk individuals of which more than 2.6 million completed a screening FIT test have found a 5.4% positivity rate, an 85% colonoscopy completion rate, a 47.8% adenoma detection rate, a 25.3% advanced adenoma detection rate and a 5.1% colorectal cancer rate [6].
The fecal hemoglobin (f-Hb) cut-offs are set at 10 or 20 microg/g feces in majority of screening programs, depending on colorectal cancer incidence and the healthcare system's colonoscopy availability [7]. FIT result is usually read in central laboratory by specialized machines with cut-off threshold set by the health policy makers.
Mowat et al [8] have used FIT tests differently. They studied the dynamic of FIT values, before and after colonoscopy with polypectomy. They have found that the median pre-polypectomy f-Hb was significantly greater in advanced adenomas as compared to non-advanced adenomas (6.0 vs. 1.0 μg/g feces, p < 0.0001). For patients with both pre and post polypectomy FIT, the dynamic showed a significant decrease for advanced adenomas (19.2 microg/g pre-polypectomy decreasing to 3.5 microg/g post-polypectomy, p=0.01) and remained fairly constant and low for non-advanced adenomas (0.8 microg/g pre-polypectomy to 1.0 microg/g post-polypectomy, p = 0.96). To note that the authors recommended patients that the second FIT test be taken after 3-weeks to allow healing of colorectal resection site, an interval arbitrarily chosen based on experience. This would theoretically avoid false positive elevated quantitative FIT test values due to occult bleeding form the resection site.
Maybe we can use FIT for DPPB surveillance. There are, however, few obstacles:
- The time to epithelization of a resection site is unknown, possibly 3-weeks as Mowat et al [8] have assumed. It depends on lesion size and whether the resection site has been closed with metallic clips.
- The occult bleeding from the resection site depends on time to epithelization, the prophylactic coagulation of vessels at the end of the procedure (snare tip, APC, CoagGrasper), the use of hemostatic gel (Purastat).
- The probability of positive FIT depends on the occult bleeding from the resection site, location (rectum versus right colon) and FIT cut-off value.
- FIT laboratory central reading for quantitative tests takes a certain amount of time (post office time) which defies the purpose of a rapid result for an immediate individual predictive information.
- DPPB mostly occurs in the first week after polypectomy and extremely rarely in the second week after polypectomy [4].
There are a lot of known unknowns and unknown unknowns.
We propose to use a rapid qualitative FIT test to be self-administered daily by the patient in the first 2 weeks after colonoscopy, after each passage of feces.
This will hopefully identify a desirable dynamic pattern of FIT results:
- Positive daily until day X, negative afterwards
- Positive daily until day X, negative afterwards, but then again positive in day Y just before DPPB We could hypothetically, do a rapid test in the day Y and if negative maybe leave the patient go about his usual activities, hobbies, and holidays.
The proposed qualitative rapid FIT is HEMOTRUST (Biosyntex, Switzerland, www.biosyntex.com). The cut-off for HEMOTRUST is 6 microg/g, which is lower than advanced adenoma pre-polypectomy values and higher than post-polypectomy values for both advanced and non-advanced adenomas [8].
Aim of the research project We aim to study the DPPB predictive value of FIT after resection of advanced colorectal adenomas.
Question of the research project Is there a dynamic of f-Hb presence after resection of advanced adenomas? Is this dynamic different in patients with DPPB after resection of advanced adenomas? Could we predict DPPB by studying f-Hb dynamic using qualitative rapid FIT?
Hypothesis The f-Hb assessment dynamic using qualitative rapid FIT may help predict DPPB at the individual level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post polypectomy cohort | – | Diagnostic Test: FIT (fecal immunochemical test) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient above 18 years old with the indication of colonoscopy, satisfying inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Patient with at least one advanced adenoma > 10mm diameter resected at colonoscopy by polypectomy, EMR, underwater EMR or ESD
- Age > 18 years old
- Written informed consent.
Key exclusion criteria (4 listed)
- Synchronous advanced colorectal cancer
- Synchronous unresected advanced adenomas
- Concomitant inflammatory bowel disease or any active colitis
- Absence of written informed consent
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 |
|---|---|---|
| FIT (fecal immunochemical test)A FIT (fecal immunochemical test) will be done daily for the 14 days following polypectomy. | Diagnostic test | Post polypectomy cohort |
Primary outcome
Day of maximum probability of positive FIT to detect delayed post polypectomy bleeding
Time frame: 14 days
Day (1 - 14) of positive FIT with maximum 24h before delayed post polypectomy bleeding
2 secondary outcomes
Time to delayed post polypectomy bleeding
Time frame: 14 days
Time of FIT positivity after polypectomy with no delayed post polypectomy bleeding
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 25681402Hassan C, Repici A, Sharma P, Correale L, Zullo A, Bretthauer M, Senore C, Spada C, Bellisario C, Bhandari P, Rex DK. Efficacy and safety of endoscopic resection of large colorectal polyps: a systematic review and meta-analysis. Gut. 2016 May;65(5):806-20. doi: 10.1136/gutjnl-2014-308481. Epub 2015 Feb 13.
- Background: PubMed 28779355Jaruvongvanich V, Prasitlumkum N, Assavapongpaiboon B, Suchartlikitwong S, Sanguankeo A, Upala S. Risk factors for delayed colonic post-polypectomy bleeding: a systematic review and meta-analysis. Int J Colorectal Dis. 2017 Oct;32(10):1399-1406. doi: 10.1007/s00384-017-2870-0. Epub 2017 Aug 5.
- Background: PubMed 34609301Huai J, Ye X, Ding J. Nomogram for the Prediction of Delayed Colorectal Post-Polypectomy Bleeding. Turk J Gastroenterol. 2021 Sep;32(9):727-734. doi: 10.5152/tjg.2021.20842.
- Background: PubMed 36341244Lu Y, Zhou X, Chen H, Ding C, Si X. Establishment of a model for predicting delayed post-polypectomy bleeding: A real-world retrospective study. Front Med (Lausanne). 2022 Oct 19;9:1035646. doi: 10.3389/fmed.2022.1035646. eCollection 2022.
- Background: PubMed 35820780Monahan KJ, Davies MM, Abulafi M, Banerjea A, Nicholson BD, Arasaradnam R, Barker N, Benton S, Booth R, Burling D, Carten RV, D'Souza N, East JE, Kleijnen J, Machesney M, Pettman M, Pipe J, Saker L, Sharp L, Stephenson J, Steele RJ. Faecal immunochemical testing (FIT) in patients with signs or symptoms of suspected colorectal cancer (CRC): a joint guideline from the Association of Coloproctology of Great Britain and Ireland (ACPGBI) and the British Society of Gastroenterology (BSG). Gut. 2022 Jul 12;71(10):1939-62. doi: 10.1136/gutjnl-2022-327985. Online ahead of print.
- Background: PubMed 35413330Mohan BP, Khan SR, Daugherty E, Chandan S, Ponnada S, Facciorusso A, Kassab LL, Asokkumar R, Adler DG. Pooled rates of adenoma detection by colonoscopy in asymptomatic average-risk individuals with positive fecal immunochemical test: a systematic review and meta-analysis. Gastrointest Endosc. 2022 Aug;96(2):208-222.e14. doi: 10.1016/j.gie.2022.04.004. Epub 2022 Apr 9.
- Background: PubMed 37380865Pokharel R, Lin YS, McFerran E, O'Mahony JF. A Systematic Review of Cost-Effectiveness Analyses of Colorectal Cancer Screening in Europe: Have Studies Included Optimal Screening Intensities? Appl Health Econ Health Policy. 2023 Sep;21(5):701-717. doi: 10.1007/s40258-023-00819-3. Epub 2023 Jun 28.
- Background: PubMed 35235491Mowat C, Digby J, Cleary S, Gray L, Datt P, Goudie DR, Steele RJ, Strachan JA, Humphries A, Fraser CG. Faecal haemoglobin concentration in adenoma, before and after polypectomy, approaches the ideal tumour marker. Ann Clin Biochem. 2022 Jul;59(4):272-276. doi: 10.1177/00045632221080897. Epub 2022 Mar 2.
Related trials for Polyp Colorectal
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
Enrolling by invitation
Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection
Colon Polyp, Adenoma
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.
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 Polyp Colorectal and Bleeding, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
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 4 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 7 May 2024. 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 Romania. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day of maximum probability of positive FIT to detect delayed post polypectomy bleeding (time frame: 14 days). 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 NCT06220149, which also lists 8 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 7 May 2024.