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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Canarias
ClinicalTrials.gov Identifier:
NCT01557101
First received: March 13, 2012
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer, Genetics of
Procedure: COLON CAPSULE ENDOSCOPY ADHERENCE
Procedure: OPTICAL COLONOSCOPY ADHERENCE
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of Colon Capsule Endoscopy as Colorectal Cancer Method of Screening in The Familiar-Risk Population

Resource links provided by NLM:


Further study details as provided by Hospital Universitario de Canarias:

Primary Outcome Measures:
  • Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer [ Time Frame: 6 month follow up ] [ Designated as safety issue: Yes ]
    Assess whether colon capsule endoscopy increases participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer


Enrollment: 200
Study Start Date: April 2012
Study Completion Date: June 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
COLON CAPSULE ENDOSCOPY Procedure: COLON CAPSULE ENDOSCOPY ADHERENCE
An exploration with a COLON CAPSULE ENDOSCOPY eaten which capsule has a video-camera in both end to see the colon.
OPTICAL COLONOSCOPY Procedure: OPTICAL COLONOSCOPY ADHERENCE
An exploration with an OPTICAL COLONOSCOPY from the anus to see the colon.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557101

Locations
Spain
Hospital Universitario de Canarias
La Laguna, S/c de Tenerife, Spain, 38320
Digestive Service, Huc
La Laguna, S/c de Tenerife, Spain, 38320
Sponsors and Collaborators
Hospital Universitario de Canarias
Investigators
Principal Investigator: Enrique Quintero, MD. PhD. Hospital Universitario de Canarias
  More Information

No publications provided

Responsible Party: Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT01557101     History of Changes
Other Study ID Numbers: CEC_cribado_CCR
Study First Received: March 13, 2012
Last Updated: January 8, 2014
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 20, 2014