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

NCT ID: NCT01766479

Last Updated: 2013-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

844 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Neoplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

CT colonography

Intervention Type RADIATION

Interventions

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CT colonography

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Contraindications to colonoscopy or CT colonography
* Pregnancy
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Michele Tedeschi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istituto Clinico humanitas

Milan, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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MTedeschi

Identifier Type: -

Identifier Source: org_study_id

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