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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT01766479
First received: December 31, 2012
Last updated: January 10, 2013
Last verified: January 2013

December 31, 2012
January 10, 2013
May 2009
September 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01766479 on ClinicalTrials.gov Archive Site
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Non-cathartic Computed Tomographic Colonography to Screen Subjects With a Family History of Colorectal Cancer
Non-cathartic Computed Tomographic Colonography to Screen for Colorectal Neoplasia in Subjects With a Family History of Colorectal Cancer

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.

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Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Screening
Colorectal Neoplasia
Radiation: CT colonography
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.
Intervention: Radiation: CT colonography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
844
November 2012
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to colonoscopy or CT colonography
  • Pregnancy
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01766479
MTedeschi
No
Michele Tedeschi, Istituto Clinico Humanitas
Istituto Clinico Humanitas
Not Provided
Not Provided
Istituto Clinico Humanitas
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP