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

Primary Purpose

Colorectal Neoplasia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CT colonography
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Neoplasia focused on measuring Colorectal cancer, colorectal neoplasia, CT colonography, advanced neoplasia, colonoscopy, family history

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to colonoscopy or CT colonography
  • Pregnancy

Sites / Locations

  • Istituto Clinico humanitas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Family Degree-relatives of pts. with CRC

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 31, 2012
Last Updated
January 10, 2013
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT01766479
Brief Title
Non-cathartic Computed Tomographic Colonography to Screen Subjects With a Family History of Colorectal Cancer
Official Title
Non-cathartic Computed Tomographic Colonography to Screen for Colorectal Neoplasia in Subjects With a Family History of Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasia
Keywords
Colorectal cancer, colorectal neoplasia, CT colonography, advanced neoplasia, colonoscopy, family history

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
N/A
Enrollment
844 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Degree-relatives of pts. with CRC
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
CT colonography
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Family history for CRC (first degree) Age >40 years old Exclusion Criteria: Contraindications to colonoscopy or CT colonography Pregnancy
Facility Information:
Facility Name
Istituto Clinico humanitas
City
Milan
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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