NCT01766479|Completed
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Sponsor study identifier
interventional
844
1 country
1
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Actual (reported)Study Completion
November 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
September 2011
Actual (reported)November 2012
Actual (reported)December 31, 2012
Actual (reported)January 11, 2013
Actual (reported)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.
up to 2 years
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Istituto Clinico humanitas
Milan, Italy, 20089, Italy
844 participants (actual enrollment reported by the registry).
First Submitted
December 31, 2012
First Posted
January 11, 2013
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications
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Primary Completion
September 2011
Actual (reported)Study Completion
November 2012
Actual (reported)Last Updated
January 11, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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