Non-cathartic Computed Tomographic Colonography to Screen Subjects With a Family History of Colorectal Cancer
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Purpose
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 | Intervention |
|---|---|
|
Colorectal Neoplasia |
Radiation: CT colonography |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Caregiver) Primary Purpose: Screening |
| Official Title: | Non-cathartic Computed Tomographic Colonography to Screen for Colorectal Neoplasia in Subjects With a Family History of Colorectal Cancer |
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 844 |
| Study Start Date: | May 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Family history for CRC (first degree)
- Age >40 years old
Exclusion Criteria:
- Contraindications to colonoscopy or CT colonography
- Pregnancy
Contacts and Locations More Information
No publications provided
| Responsible Party: | Michele Tedeschi, MD, Istituto Clinico Humanitas |
| ClinicalTrials.gov Identifier: | NCT01766479 History of Changes |
| Other Study ID Numbers: | MTedeschi |
| Study First Received: | December 31, 2012 |
| Last Updated: | January 10, 2013 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Istituto Clinico Humanitas:
|
Colorectal cancer colorectal neoplasia CT colonography |
advanced neoplasia colonoscopy family history |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013