Trial Review

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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
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
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.