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Non-cathartic Computed Tomographic Colonography to Screen Subjects With a Family History of Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01766479
First Posted: January 11, 2013
Last Update Posted: January 11, 2013
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas
  Purpose

Background: Although subjects with first-degree relatives (FDR) with a history of colorectal cancer (CRC) are at increased risk for CRC, compliance to screening colonoscopy is suboptimal. Computed tomographic colonography (CTC) has been recognized as an alternative for CRC screening in average risk subjects, but less information is available on its performance in FDRs.

Aims: To prospectively assess the accuracy of CTC as a screening tool in FDRs using colonoscopy (OC) with segmental unblinding as reference standard.

Methods: Consecutive patients admitted with CRC diagnosis (index case, IC) were prospectively evaluated. Following the systematic identification of ICs with inherited predispositions to CRC, ICs who agreed to contact their FDRs ≥40 years old were included. Available FDRs were invited to undergo non-cathartic CTC, with OC the following day. Sensitivity/specificity/PPV/NPV of CTC was assessed for detecting subjects with any lesion ≥6 mm, ≥10 mm, and for advanced neoplasia ≥6 mm.


Condition Intervention
Colorectal Neoplasia Radiation: CT colonography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Screening
Official Title: Non-cathartic Computed Tomographic Colonography to Screen for Colorectal Neoplasia in Subjects With a Family History of Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Michele Tedeschi, Istituto Clinico Humanitas:

Primary Outcome Measures:
  • Number of patients in whom colorectal polyps and colorectal neoplasia have been detected by CT colonography, by adopting colonoscopy as gold standard, as a measure of efficacy. [ Time Frame: up to 2 years ]

Enrollment: 844
Study Start Date: May 2009
Study Completion Date: November 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family Degree-relatives of pts. with CRC
Consecutive patients admitted with CRC diagnosis (index case, IC) were prospectively evaluated. Following the systematic identification of ICs with inherited predispositions to CRC, ICs who agreed to contact their FDRs ≥40 years old were included. Available FDRs were invited to undergo non-cathartic CTC, with OC the following day.
Radiation: CT colonography

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Family history for CRC (first degree)
  • Age >40 years old

Exclusion Criteria:

  • Contraindications to colonoscopy or CT colonography
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766479


Locations
Italy
Istituto Clinico humanitas
Milan, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
  More Information

Responsible Party: Michele Tedeschi, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT01766479     History of Changes
Other Study ID Numbers: MTedeschi
First Submitted: December 31, 2012
First Posted: January 11, 2013
Last Update Posted: January 11, 2013
Last Verified: January 2013

Keywords provided by Michele Tedeschi, Istituto Clinico Humanitas:
Colorectal cancer
colorectal neoplasia
CT colonography
advanced neoplasia
colonoscopy
family history

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