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Comparison Colon Capsule Endoscopy vs Optical Colonoscopy for Colorectal Cancer Screening in Familiar-Risk Population (CRIBADO)

Primary Purpose

Colorectal Cancer, Genetics of

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
COLON CAPSULE ENDOSCOPY ADHERENCE
OPTICAL COLONOSCOPY ADHERENCE
Sponsored by
Hospital Universitario de Canarias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer, Genetics of

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Asymptomatic first-degree relatives (parents, siblings or children) of CRC patients aged less than 60 years or with two or more first-degree relatives of any age.
  • Signing of informed consent.

Exclusion Criteria:

  • Personal history of adenoma or CRC.
  • History of hereditary CRC.
  • Chronic inflammatory disease.
  • Presence of digestive symptoms.
  • Patients with swallowing problems (dysphagia).
  • Personal history of gastrointestinal surgery.
  • Enteritis radioactive.
  • Renal failure.
  • Congestive heart failure
  • Allergy or other contraindication to Bysacodyl to PEG or phosphates.
  • Pregnancy.
  • Suspected bowel obstruction or intestinal strictures or fistulas known.
  • Colectomy.
  • Paralysis with impaired intestinal motility.
  • Any other process that the investigator's discretion to make inadequate participation.

Sites / Locations

  • Digestive Service, Huc
  • Hospital Universitario de Canarias

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

COLON CAPSULE ENDOSCOPY

OPTICAL COLONOSCOPY

Arm Description

Outcomes

Primary Outcome Measures

Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer
Assess whether colon capsule endoscopy increases participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer

Secondary Outcome Measures

Full Information

First Posted
March 13, 2012
Last Updated
January 8, 2014
Sponsor
Hospital Universitario de Canarias
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1. Study Identification

Unique Protocol Identification Number
NCT01557101
Brief Title
Comparison Colon Capsule Endoscopy vs Optical Colonoscopy for Colorectal Cancer Screening in Familiar-Risk Population
Acronym
CRIBADO
Official Title
Effectiveness of Colon Capsule Endoscopy as Colorectal Cancer Method of Screening in The Familiar-Risk Population
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario de Canarias

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if the adherence to screening in first grade relatives of patients with CCR is higher than optical colonoscopy.
Detailed Description
The purpose of this study is to compare the adherence and effectiveness of colon capsule endoscopy (CCE-2) versus conventional colonoscopy to screen first-degree relatives of patients with colorectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Genetics of

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COLON CAPSULE ENDOSCOPY
Arm Type
Other
Arm Title
OPTICAL COLONOSCOPY
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
COLON CAPSULE ENDOSCOPY ADHERENCE
Intervention Description
An exploration with a COLON CAPSULE ENDOSCOPY eaten which capsule has a video-camera in both end to see the colon.
Intervention Type
Procedure
Intervention Name(s)
OPTICAL COLONOSCOPY ADHERENCE
Intervention Description
An exploration with an OPTICAL COLONOSCOPY from the anus to see the colon.
Primary Outcome Measure Information:
Title
Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer
Description
Assess whether colon capsule endoscopy increases participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer
Time Frame
6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Asymptomatic first-degree relatives (parents, siblings or children) of CRC patients aged less than 60 years or with two or more first-degree relatives of any age. Signing of informed consent. Exclusion Criteria: Personal history of adenoma or CRC. History of hereditary CRC. Chronic inflammatory disease. Presence of digestive symptoms. Patients with swallowing problems (dysphagia). Personal history of gastrointestinal surgery. Enteritis radioactive. Renal failure. Congestive heart failure Allergy or other contraindication to Bysacodyl to PEG or phosphates. Pregnancy. Suspected bowel obstruction or intestinal strictures or fistulas known. Colectomy. Paralysis with impaired intestinal motility. Any other process that the investigator's discretion to make inadequate participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Quintero, MD. PhD.
Organizational Affiliation
Hospital Universitario de Canarias
Official's Role
Principal Investigator
Facility Information:
Facility Name
Digestive Service, Huc
City
La Laguna
State/Province
S/c de Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
S/c de Tenerife
ZIP/Postal Code
38320
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26133904
Citation
Adrian-de-Ganzo Z, Alarcon-Fernandez O, Ramos L, Gimeno-Garcia A, Alonso-Abreu I, Carrillo M, Quintero E. Uptake of Colon Capsule Endoscopy vs Colonoscopy for Screening Relatives of Patients With Colorectal Cancer. Clin Gastroenterol Hepatol. 2015 Dec;13(13):2293-301.e1. doi: 10.1016/j.cgh.2015.06.032. Epub 2015 Jun 29.
Results Reference
derived

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Comparison Colon Capsule Endoscopy vs Optical Colonoscopy for Colorectal Cancer Screening in Familiar-Risk Population

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