Non-cathartic Computed Tomographic Colonography to Screen Subjects With a Family History of Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT01766479|
Recruitment Status : Completed
First Posted : January 11, 2013
Last Update Posted : January 11, 2013
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 or disease||Intervention/treatment||Phase|
|Colorectal Neoplasia||Radiation: CT colonography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||844 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Non-cathartic Computed Tomographic Colonography to Screen for Colorectal Neoplasia in Subjects With a Family History of Colorectal Cancer|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||November 2012|
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|
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766479
|Istituto Clinico humanitas|
|Milan, Italy, 20089|