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

Istituto Clinico Humanitas

Status: Completed

Conditions: Colorectal Neoplasia

Treatments: Radiation: CT colonography

Study type: Interventional

Funder types: Other

Identifiers

NCT01766479

MTedeschi

Details and patient eligibility

About

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.

Enrollment: 844 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Contraindications to colonoscopy or CT colonography
• Pregnancy

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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844 participants in 1 patient group

Family Degree-relatives of pts. with CRC

Experimental group

Description:

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.

Treatment:

Radiation: CT colonography