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

NCT01766479 | Completed

• 1 other identifier: MTedeschi
• Study Type: interventional
• Target: 844
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasia

Keywords

Colorectal cancer; colorectal neoplasia; CT colonography; advanced neoplasia; colonoscopy; family history

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Family Degree-relatives of pts. with CRC

EXPERIMENTAL

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

Interventions

CT colonography RADIATION

Family Degree-relatives of pts. with CRC

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contraindications to colonoscopy or CT colonography
• Pregnancy

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico humanitas

Milan, Italy, 20089, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 31, 2012
• First Posted: January 11, 2013
• Study Start: May 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2012
• Last Updated: January 11, 2013

Record last verified: 2013-01

Locations

IT (1)