Small Intestine CancerNCT02325232
Enteroscopy for Early Diagnosis of Tumors in Celiac Disease
A study testing Capsule endoscopy, double balloon enteroscopy sequential use in people with Small Intestine Cancer and Celiac Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Celiac disease (CD) is the most common chronic autoimmune enteropathy in Western Countries with an estimated prevalence ranging from 1:100 to 1:200. It is usually characterized by a benign course with clinical and histological remission, provided that a strict gluten-free diet (GFD) is followed by patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Intestine Cancer, Celiac Disease
- What is being tested?
- Capsule endoscopy, double balloon enteroscopy sequential use
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2012to Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of celiac disease when aged over 50 years, with persistence/recurrence of gastrointestinal symptoms after 6 months on gluten free diet ii) lack of compliance to gluten free diet (defined as conscious and regular gluten ingestion for at least two years) iii) presence of alarm symptoms/signs, either at diagnosis or during the follow up
Who cannot join
- age lower than 18 years
- absence of written informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Celiac Disease Center, Fondazione IRCCS Cà Granda
Milan, 20122
Luca Elli, MD PhD, 00390255033384, lucelli@yahoo.com
About this study
Official title: A Capsule Endoscopy and Double Balloon Enteroscopy Sequential Approach for Early Detection of Gastrointestinal Tumors in Celiac Disease: a Prospective Trial
Celiac disease (CD) is the most common chronic autoimmune enteropathy in Western Countries with an estimated prevalence ranging from 1:100 to 1:200. It is usually characterized by a benign course with clinical and histological remission, provided that a strict gluten-free diet (GFD) is followed by patients. Less frequently, CD can be characterized by a complicated course, when facing with a refractory disease (RCD) or with malignancies of the gastrointestinal (GI) tract, namely lymphoma and adenocarcinoma of the small bowel (SB). Different studies estimated a relative risk (RR) for neoplastic GI complications in CD ranging from 2 to 40 and from 10 to 60 for primary gut lymphoma and adenocarcinoma, respectively. Although uncommon, the discussed malignancies has a severe prognosis, reflecting the need for an early diagnosis. This project aims to establish an enteroscopic approach to improve the diagnostic timing and survival of CD patients at risk to develop SB tumors.
Read the detailed description
In the last years, the difficulty to explore SB represented a problem for an early diagnosis of the intestinal tumors. Small bowel videocapsule endoscopy (VCE) and double-balloon enteroscopy (DBE) currently represent the diagnostic gold standard for the SB mucosal lesions. The enteroscopic techniques have been applied for both the diagnosis and management of patients with complicated CD, even if the currently available data are derived from retrospective investigations. Moreover,different clinical and demographic risk factors for SB tumors in CD have been identified; thus, the following statements should be taken in consideration to plan a diagnostic strategy for SB malignancies in a subset of CD patients: i) the risk of GI malignancy in CD is not homogenously distributed; ii) attention should be paid to CD patients with particular demographic and clinical features; iii) in this subset of CD patients an early diagnostic strategy for SB tumors is yet to be evaluated.
Hyphotesis and Significance: In a cohort of CD patients with particular clinical and demographic characteristics is possible to establish a programme for early diagnosis of small bowel complications. Specific Aim:To identify CD patients at higher risk of developing small bowel neoplasia and to evaluate, in this subset, the usefulness of VCE and DBE. To evaluate the diagnostic yeld of DBE and VCE in this setting of patients. To establish a flowchart for early diagnosis of small bowel tumors in CD patients.
It is our intention to evaluate at least 180-240 CD patients satisfying the entry criteria, to be enrolled during the three years. At least 500 OGIB controls will be enrolled including the prospective and retrospective (VCE lombard registry) parts (rate of SB tumors in this group 0.6%, see image of preliminary data). The known rate of SB tumors in the general population is 0.009%. It is expected a rate of SB tumors in selected CD of 5% (data from the preliminary findings). Comparison between groups (5% level of significance), if these neoplastic rates and result expectation should be confirmed, has a statistical power greater than 80%. All the assumptions will be verified using SPSS ver. 18. A P value of <0.05 will be considered statistically significant (significance level of the tests 5%, two tails). As mentioned, the sample size has been calculated presuming a 5%prevalence of malignancies in the CD cohort. The normal distribution of the sample will be verified through the Kolmogorov-Smirnov test. Continuous variables will be analyzed with the Anova Oneway variance test or with the non parametric Kruskal-Wallis test. The significance level will be further verified by multiple comparison analysis (Tukey or Mann-Whitney' s test). Categorical variables will be compared wih X2 or Fisher' s Exact test.
- Conditions
- Small Intestine Cancer, Celiac Disease
- Being tested
- Capsule endoscopy, double balloon enteroscopy sequential use
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule endoscopy, double balloon enteroscopy sequential useDevice
Small bowel capsule endoscopy followed by double-balloon enteroscopy with histological sampling in case of mucosal alterations
| Study group | Role | What they receive |
|---|---|---|
| Enteroscopy | Experimental | Capsule endoscopy, double balloon enteroscopy sequential use Receives: Device: Capsule endoscopy, double balloon enteroscopy sequential use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of celiac patients at higher risk of developing small bowel neoplasia and evaluation of the the usefulness of VCE and DBE
Consecutive CD patients attending to the "Center for Prevention and Diagnosis of Celiac Disease", "Fondazione IRCCS CàGranda-Ospedale Maggiore Policlinico - Milano" will be prospectively evaluated.The subjects fulfilling the entry criteria giving their written consent to the study will undergo the following work-up: routineblood tests, upper GI endoscopy with biopsies; determination of histologic grading (Marsh-Oberhuber grading) and CD3/CD8 immunohistochemistry; VCE. Abdominal and small bowel ultrasounds. Further investigations will be carried out when clinically indicated. In detail: DBE when facing with positive findings at VCE. It is planned to enroll 60-80 CD patients/years and controls with an expected prevalence of tumors of 5% and 0.5% in CD and controls respectively.
Measured: After 18 months an interim analysis has been planned; At the end of the project, after 36 months, the achievement of the expected number of cases is planned, complete of all the statistical analysis.
Secondary outcomes (1)
The diagnostic yeld of DBE and VCE in this setting of patients
The diagnostic yeld of VCE and DBE sequential approach in celiac patients will be compared to that of non-celiac patients, matched for sex and age and undergoing VCE for obscure gastrointestinal bleeding (OGIB). This cohort of control patientswill be prospectively selected at the "Fondazione IRCCS Cà Granda" and will be also taken, retrospectively, from the VCELombardy Registry, collecting about 2500 cases of OGIB VCE from 2010. Moreover, the incidence of the tumor typesdiagnosed in CD will be compared to that of a registered population (from the Lombardy Cancer Registry) covering all theresidents in the province of Varese (815,362 inhabitants), as an index representative of the incidence of these tumors in thegeneral population.
Measured: After 18 months an interim analysis has been planned; At the end of the project, after 36 months, the achievement of the expected number of cases is planned, complete of all the statistical analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startFeb 2012
- Primary completionMay 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Intestine CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Elli, MD PhD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325232
- Sponsor's protocol ID
- 167
- Other IDs
- GR-2011-02348234
- Status last verified
- Jul 2015
- First submitted
- 19 Dec 2014
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Capsule Endoscopy and Double Balloon Enteroscopy Sequential Approach for Early Detection of Gastrointestinal Tumors in Celiac Disease: a Prospective Trial
- ClinicalTrials.gov ID
- NCT02325232
- Acronym / sponsor ID
- 167
- Conditions
- Small Intestine Cancer, Celiac Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 24 Dec 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.
Celiac disease (CD) is the most common chronic autoimmune enteropathy in Western Countries with an estimated prevalence ranging from 1:100 to 1:200. It is usually characterized by a benign course with clinical and histological remission, provided that a strict gluten-free diet (GFD) is followed by patients. Less frequently, CD can be characterized by a complicated course, when facing with a refractory disease (RCD) or with malignancies of the gastrointestinal (GI) tract, namely lymphoma and adenocarcinoma of the small bowel (SB). Different studies estimated a relative risk (RR) for neoplastic GI complications in CD ranging from 2 to 40 and from 10 to 60 for primary gut lymphoma and adenocarcinoma, respectively. Although uncommon, the discussed malignancies has a severe prognosis, reflecting the need for an early diagnosis. This project aims to establish an enteroscopic approach to improve the diagnostic timing and survival of CD patients at risk to develop SB tumors.
Detailed description
In the last years, the difficulty to explore SB represented a problem for an early diagnosis of the intestinal tumors. Small bowel videocapsule endoscopy (VCE) and double-balloon enteroscopy (DBE) currently represent the diagnostic gold standard for the SB mucosal lesions. The enteroscopic techniques have been applied for both the diagnosis and management of patients with complicated CD, even if the currently available data are derived from retrospective investigations. Moreover,different clinical and demographic risk factors for SB tumors in CD have been identified; thus, the following statements should be taken in consideration to plan a diagnostic strategy for SB malignancies in a subset of CD patients: i) the risk of GI malignancy in CD is not homogenously distributed; ii) attention should be paid to CD patients with particular demographic and clinical features; iii) in this subset of CD patients an early diagnostic strategy for SB tumors is yet to be evaluated.
Hyphotesis and Significance: In a cohort of CD patients with particular clinical and demographic characteristics is possible to establish a programme for early diagnosis of small bowel complications. Specific Aim:To identify CD patients at higher risk of developing small bowel neoplasia and to evaluate, in this subset, the usefulness of VCE and DBE. To evaluate the diagnostic yeld of DBE and VCE in this setting of patients. To establish a flowchart for early diagnosis of small bowel tumors in CD patients.
It is our intention to evaluate at least 180-240 CD patients satisfying the entry criteria, to be enrolled during the three years. At least 500 OGIB controls will be enrolled including the prospective and retrospective (VCE lombard registry) parts (rate of SB tumors in this group 0.6%, see image of preliminary data). The known rate of SB tumors in the general population is 0.009%. It is expected a rate of SB tumors in selected CD of 5% (data from the preliminary findings). Comparison between groups (5% level of significance), if these neoplastic rates and result expectation should be confirmed, has a statistical power greater than 80%. All the assumptions will be verified using SPSS ver. 18. A P value of <0.05 will be considered statistically significant (significance level of the tests 5%, two tails). As mentioned, the sample size has been calculated presuming a 5%prevalence of malignancies in the CD cohort. The normal distribution of the sample will be verified through the Kolmogorov-Smirnov test. Continuous variables will be analyzed with the Anova Oneway variance test or with the non parametric Kruskal-Wallis test. The significance level will be further verified by multiple comparison analysis (Tukey or Mann-Whitney' s test). Categorical variables will be compared wih X2 or Fisher' s Exact test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enteroscopy | Experimental | Device: Capsule endoscopy, double balloon enteroscopy sequential useCapsule endoscopy, double balloon enteroscopy sequential use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of celiac disease when aged over 50 years, with persistence/recurrence of gastrointestinal symptoms after 6 months on gluten free diet ii) lack of compliance to gluten free diet (defined as conscious and regular gluten ingestion for at least two years) iii) presence of alarm symptoms/signs, either at diagnosis or during the follow up
Key exclusion criteria (2 listed)
- age lower than 18 years
- absence of written informed consent to participate in the study
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 |
|---|---|---|
| Capsule endoscopy, double balloon enteroscopy sequential useSmall bowel capsule endoscopy followed by double-balloon enteroscopy with histological sampling in case of mucosal alterations | Device | Enteroscopy |
Primary outcome
Identification of celiac patients at higher risk of developing small bowel neoplasia and evaluation of the the usefulness of VCE and DBE
Time frame: After 18 months an interim analysis has been planned; At the end of the project, after 36 months, the achievement of the expected number of cases is planned, complete of all the statistical analysis.
Consecutive CD patients attending to the "Center for Prevention and Diagnosis of Celiac Disease", "Fondazione IRCCS CàGranda-Ospedale Maggiore Policlinico - Milano" will be prospectively evaluated.The subjects fulfilling the entry criteria giving their written consent to the study will undergo the following work-up: routineblood tests, upper GI endoscopy with biopsies; determination of histologic grading (Marsh-Oberhuber grading) and CD3/CD8 immunohistochemistry; VCE. Abdominal and small bowel ultrasounds. Further investigations will be carried out when clinically indicated. In detail: DBE when facing with positive findings at VCE. It is planned to enroll 60-80 CD patients/years and controls with an expected prevalence of tumors of 5% and 0.5% in CD and controls respectively.
1 secondary outcome
The diagnostic yeld of DBE and VCE in this setting of patients
Time frame: After 18 months an interim analysis has been planned; At the end of the project, after 36 months, the achievement of the expected number of cases is planned, complete of all the statistical analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
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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.
Luca Elli, MD PhD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsule endoscopy, double balloon enteroscopy sequential use in people with Small Intestine Cancer and Celiac Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site 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 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: status not confirmed, as of the sponsor's last update on 27 Aug 2015. 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 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 Luca Elli, MD PhD (00390255033384, lucelli@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of celiac patients at higher risk of developing small bowel neoplasia and evaluation of the the usefulness of VCE and DBE (time frame: After 18 months an interim analysis has been planned; At the end of the project, after 36 months, the achievement of the expected number of cases is planned, complete of all the statistical analysis.). 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 27 Aug 2015.