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
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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COMPLETED
NA
844 participants
INTERVENTIONAL
2009-05-31
2012-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
SINGLE
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.
CT colonography
Interventions
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CT colonography
Eligibility Criteria
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Inclusion Criteria
* Age \>40 years old
Exclusion Criteria
* Pregnancy
40 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Michele Tedeschi
MD
Locations
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Istituto Clinico humanitas
Milan, Italy, Italy
Countries
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Other Identifiers
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MTedeschi
Identifier Type: -
Identifier Source: org_study_id
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