Comparison Colon Capsule Endoscopy vs Optical Colonoscopy for Colorectal Cancer Screening in Familiar-Risk Population
CRIBADO
Effectiveness of Colon Capsule Endoscopy as Colorectal Cancer Method of Screening in The Familiar-Risk Population
1 other identifier
interventional
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2012
CompletedFirst Posted
Study publicly available on registry
March 19, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJanuary 9, 2014
January 1, 2014
1 year
March 13, 2012
January 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 month follow up
Study Arms (2)
COLON CAPSULE ENDOSCOPY
OTHEROPTICAL COLONOSCOPY
OTHERInterventions
An exploration with a COLON CAPSULE ENDOSCOPY eaten which capsule has a video-camera in both end to see the colon.
An exploration with an OPTICAL COLONOSCOPY from the anus to see the colon.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Digestive Service, Huc
San Cristóbal de La Laguna, S/c de Tenerife, 38320, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, S/c de Tenerife, 38320, Spain
Related Publications (1)
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.
PMID: 26133904DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Enrique Quintero, MD. PhD.
Hospital Universitario de Canarias
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2012
First Posted
March 19, 2012
Study Start
April 1, 2012
Primary Completion
April 1, 2013
Study Completion
June 1, 2013
Last Updated
January 9, 2014
Record last verified: 2014-01