Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05704010
Status:
RECRUITING
Last Update Posted:
2023-01-31
First Post:
2023-01-13
Brief Title:
Videocapsule Endoscopy in Lynch Syndrome
Sponsor:
San Raffaele University
Organization:
San Raffaele University
Study Overview
Official Title:
Role of Videocapsule Endoscopy in Lynch Syndrome a Multicenter Italian Registry Study
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Lynch syndrome is caused by a pathogenic variant in one of the four Mismatch Repair genes MMR MLH1 MSH2Epcam MSH6 or PMS2 These pathogenic variants confer a higher risk of developing colorectal and other cancers including small bowel cancer The risk of developing a small bowel adenocarcinoma is about 100 times higher compared to individuals without Lynch syndrome and the lifetime risk of small bowel cancer is estimated at 42
The diagnosis of a small bowel cancer depends on videocapsule endoscopy VCE This device is swalled so that it can record images of the small bowel which are then stored on a wearable device for about 8 hours The capsule is then expelled in the feces while the images are transferred to a computer to be analysed To date there is conflicting evidence on the efficacy of small bowel cancer screening with VCE
Rationale this registry study will collect prospective data from patients with LS undergoing VCE
Aim evaluate the incidence of neoplastic and pre-neoplastic lesions in patients with LS during a VCE-based small bowel cancer screening study
Design this is a multicentric observational study that analyzes data from diagnostic techniques already approved Patients will not undergo diagnostic procedures beyond what would be recommended by clinical practice
The diagnosis of a small bowel cancer depends on videocapsule endoscopy VCE This device is swalled so that it can record images of the small bowel which are then stored on a wearable device for about 8 hours The capsule is then expelled in the feces while the images are transferred to a computer to be analysed To date there is conflicting evidence on the efficacy of small bowel cancer screening with VCE
Rationale this registry study will collect prospective data from patients with LS undergoing VCE
Aim evaluate the incidence of neoplastic and pre-neoplastic lesions in patients with LS during a VCE-based small bowel cancer screening study
Design this is a multicentric observational study that analyzes data from diagnostic techniques already approved Patients will not undergo diagnostic procedures beyond what would be recommended by clinical practice
Detailed Description:
Background Lynch syndrome LS is caused by a pathogenic germline defect in one of the mismatch repair genes MMR namely MLH1 MSH2Epcam MSH6 or PMS2 Such pathogenic defects confer a higher risk of developing not only colorectal cancer but also small bowel cancer SBC Patients with LS have a lifetime risk of SMB of 42 with a relative risk of 100 compared to the general population Moreover patients with LS may develop SBC at a younger age compared to SBC in individuals without LS
The diagnostic standard for SBC is video capsule endoscopy VCE This consists in swallowing a pill with a camera inside The VCE will record the images through the gastrointestinal tract and send them via Bluetooth to a wearable device for roughly 8 hours The capsule is then expelled with feces while the images are stored in a computer for later revision Today the data on the efficacy of a screening program for SBC in patients with LS is controversial
Rationale This register study will collect prospective data on the VCEs done on patients with LS
Objective To estimate the incidence of neoplasia and preneoplastic lesions of the small bowel in patients with LS via VCE
Design Multicentric observational study with the use of approved diagnostic devices It will not modify the current standard of care The study design will not mandate obligatory studies of further procedures besides those that are clinically approved
Population At least 10 subjectsyear by each center 400 patients by study completion
Controindications to VCE
Stenosis obstructions fistulas suspected or known
Cardiac defibrillators or cardiac pace-makers
Dysphagia
Inability to provide written informed consent
Pregnancy suspected or known
Risks of VCE VCE retention is the most dreaded adverse events The risk may vary between 15 and 21
Allergic reactions may be possible due to the use of sticky electrodes on the skin
Study duration 10 years from January 2016
Confounders To date not known
Data management All results will remain confidential Clinical data may become available at scientific meetings or in published articles but patient anonymity will always be maintained
Statistics The incidence of neoplastic and preneoplastic lesions of the subjects included in the study will be estimated The sample size was established on the basis of feasibility 10 subjects enrolled each year for each center in 10 years 400 patients in total The expected incidence of small bowel injury is approximately 5 With 400 subjects it is possible to estimate the incidence with an accuracy of 2 estimated with a 95 confidence interval
Descriptive statistical variables mean standard deviation median etc will be evaluated on the collected data
Any relationships between these variables will be evaluated using inferential statistics t-test chi-squared logistic regression analysis multivariate analysis etc Any relationship with a p-value less than 005 will be considered significant
Ethics The investigators declare that the study will be conducted in accordance with the ethical principles deriving from the Declaration of Helsinki and the current legislation on Observational Studies
Informed consent All subjects will be informed of the purpose of the study of the confidentiality of the personal data and of the fact that this data may be subject to review for study-related reasons by authorized person other than the physician
It will be emphasized that participation is entirely voluntary and that the patient can refuse further participation in the protocol at any time without affecting the patients subsequent care Informed consent will be obtained for all subjects included in the study prior to their inclusion in the present study in accordance with national and local regulations
The diagnostic standard for SBC is video capsule endoscopy VCE This consists in swallowing a pill with a camera inside The VCE will record the images through the gastrointestinal tract and send them via Bluetooth to a wearable device for roughly 8 hours The capsule is then expelled with feces while the images are stored in a computer for later revision Today the data on the efficacy of a screening program for SBC in patients with LS is controversial
Rationale This register study will collect prospective data on the VCEs done on patients with LS
Objective To estimate the incidence of neoplasia and preneoplastic lesions of the small bowel in patients with LS via VCE
Design Multicentric observational study with the use of approved diagnostic devices It will not modify the current standard of care The study design will not mandate obligatory studies of further procedures besides those that are clinically approved
Population At least 10 subjectsyear by each center 400 patients by study completion
Controindications to VCE
Stenosis obstructions fistulas suspected or known
Cardiac defibrillators or cardiac pace-makers
Dysphagia
Inability to provide written informed consent
Pregnancy suspected or known
Risks of VCE VCE retention is the most dreaded adverse events The risk may vary between 15 and 21
Allergic reactions may be possible due to the use of sticky electrodes on the skin
Study duration 10 years from January 2016
Confounders To date not known
Data management All results will remain confidential Clinical data may become available at scientific meetings or in published articles but patient anonymity will always be maintained
Statistics The incidence of neoplastic and preneoplastic lesions of the subjects included in the study will be estimated The sample size was established on the basis of feasibility 10 subjects enrolled each year for each center in 10 years 400 patients in total The expected incidence of small bowel injury is approximately 5 With 400 subjects it is possible to estimate the incidence with an accuracy of 2 estimated with a 95 confidence interval
Descriptive statistical variables mean standard deviation median etc will be evaluated on the collected data
Any relationships between these variables will be evaluated using inferential statistics t-test chi-squared logistic regression analysis multivariate analysis etc Any relationship with a p-value less than 005 will be considered significant
Ethics The investigators declare that the study will be conducted in accordance with the ethical principles deriving from the Declaration of Helsinki and the current legislation on Observational Studies
Informed consent All subjects will be informed of the purpose of the study of the confidentiality of the personal data and of the fact that this data may be subject to review for study-related reasons by authorized person other than the physician
It will be emphasized that participation is entirely voluntary and that the patient can refuse further participation in the protocol at any time without affecting the patients subsequent care Informed consent will be obtained for all subjects included in the study prior to their inclusion in the present study in accordance with national and local regulations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None