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

I

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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