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

Colorectal Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766479
• Other study ID #: MTedeschi
• Status: Completed
• Phase: N/A
• First received: December 31, 2012
• Last updated: January 10, 2013
• Start date: May 2009
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 844
• Est. completion date: November 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Family history for CRC (first degree)

• Age >40 years old

Exclusion Criteria:

• Contraindications to colonoscopy or CT colonography

• Pregnancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Neoplasia
• Colorectal Neoplasms
• Neoplasms

Intervention

Radiation:
• CT colonography

Locations

Country	Name	City	State
Italy	Istituto Clinico humanitas	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No