Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000468820
Ethics application status
Approved
Date submitted
28/03/2012
Date registered
30/04/2012
Date last updated
31/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Capsule endoscopy in the detection of small bowel neoplasias in patients with Lynch syndrome
Scientific title
Patients with Lynch syndrome with an identified mutation in a MMR gene will perform capsule endoscopy to evaluate the prevalence of small bowel neoplasias
Secondary ID [1] 280239 0
None
Universal Trial Number (UTN)
U1111-1129-5894
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lynch syndrome (Hereditary nonpolyposis colorectal cancer) 286191 0
Small bowel neoplasia 286192 0
Condition category
Condition code
Cancer 286389 286389 0 0
Bowel - Small bowel (duodenum and ileum)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Capsule endoscopy will be performed according with standard method:
Small bowel preparation with 2 liters of polyethylene glycol (PEG) preparation. At 5 PM on the evening prior to capsule endoscopy patients will begin drinking an 8-ounce glass of the preparation fluid (in the gallon container) every fifteen minutes until all of the liquid is consumed;

Overnight fast;

Capsule endoscopy (Mirocam) will be swallowed in the day of the exam and pictures will be taken for 12 h and collected in a recorder. The capsule is eliminated in the feces and does not need to be recovered.
The images are read in the appropriate software by an experienced physician.
Intervention code [1] 284583 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286846 0
To access the prevalence of small bowel neoplasias in patients with Lynch syndrome using capsule endoscopy findings.
Patients with relevant findings at capsule endoscopy- tumours or polyps, will be submitted to upper GI endoscopy or double ballon enetroscopy for histological confirmation.
Timepoint [1] 286846 0
At the time that capsule endoscopy is performed
Secondary outcome [1] 296804 0
Nil
Timepoint [1] 296804 0
Nil

Eligibility
Key inclusion criteria
Mismatch repair gene mutation;
Give written informed consent;
More than 40 years of age
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
GI occlusive symptoms;
unexplained weight loss in the last 2 months

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/05/2012
Actual
9/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
59
Accrual to date
Final
Recruitment outside Australia
Country [1] 4228 0
Portugal
State/province [1] 4228 0
-

Funding & Sponsors
Funding source category [1] 285002 0
Hospital
Name [1] 285002 0
Instituto Portugues de Oncologia de Lisboa. EPE
Country [1] 285002 0
Portugal
Primary sponsor type
Hospital
Name
Instituto Portugues de Oncologia de Lisboa. EPE
Address
R. prof. Lima Basto 1099-023 Lisbon
Country
Portugal
Secondary sponsor category [1] 283867 0
None
Name [1] 283867 0
Address [1] 283867 0
Country [1] 283867 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287011 0
Ethis Committee from the IPOLFG.EPE
Ethics committee address [1] 287011 0
R. prof. Lima Basto
1099-023 Lisbon
Ethics committee country [1] 287011 0
Portugal
Date submitted for ethics approval [1] 287011 0
Approval date [1] 287011 0
20/12/2011
Ethics approval number [1] 287011 0

Summary
Brief summary
The cumulative risk of small bowel neoplasias in patients with Lynch syndrome (LS) is of 4% (100 times higher than that of the normal population).
Small bowel surveillance in patients with LS is not recommended in surveillance guidelines.
Recent data from a study with a small number of patients capsule endoscopy detected small bowel neoplasias in 8,5% of asymptomatic patients with LS.
We intend to perform a prospective observational uncontrolled study in asymptomatic LS patients older than 40 years. The main endpoint of the study is to access the prevalence of small bowel neoplasias using capsule endoscopy.
All capsules will be read independently by two observers. All lesions detected will be evaluated by the two observers and a consensus will be reached.
All patients with lesions considered to be relevant and related to the LS (polyps or tumours) will be submitted to double balloon endoscopy to evaluate the lesion and to obtain a specimen for histological examination.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33996 0
Dr Susana Mao de Ferro
Address 33996 0
Gastroenterology department - Instituto Portugues de Oncologia de Lisboa Dr Francisco Gentil 1099-023 Lisbon
Country 33996 0
Portugal
Phone 33996 0
+351935924759
Fax 33996 0
Email 33996 0
[email protected]
Contact person for public queries
Name 17243 0
Susana Mao de Ferro
Address 17243 0
Gastroenterology department - Instituto Portugues de Oncologia de Lisboa Dr Francisco Gentil 1099-023 Lisbon
Country 17243 0
Portugal
Phone 17243 0
+351935924759
Fax 17243 0
+351217229855
Email 17243 0
[email protected]
Contact person for scientific queries
Name 8171 0
Susana Mao de Ferro
Address 8171 0
Gastroenterology department - Instituto Portugues de Oncologia de Lisboa Dr Francisco Gentil 1099-023 Lisbon
Country 8171 0
Portugal
Phone 8171 0
+351935924759
Fax 8171 0
+351217229855
Email 8171 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.