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

Not Applicable

Completed

• Conditions: Colorectal Neoplasia
• Interventions: Radiation: CT colonography

• Registration Number: NCT01766479
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2011-09
• Study Completion: 2012-11
• Study First Submitted: 2012-12-31
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-10
• Last Update Submitted: 2013-01-10
• Study First Posted: 2013-01-11
• Last Update Posted: 2013-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 844

Inclusion Criteria

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

Exclusion Criteria

• Contraindications to colonoscopy or CT colonography
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Family Degree-relatives of pts. with CRC	CT colonography	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Istituto Clinico humanitas; 🇮🇹 Milan, Italy