- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01766479
Non-cathartic Computed Tomographic Colonography to Screen Subjects With a Family History of Colorectal Cancer
Non-cathartic Computed Tomographic Colonography to Screen for Colorectal Neoplasia in Subjects With a Family History of Colorectal Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Milan, Italy, 20089
- Istituto Clinico Humanitas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Family history for CRC (first degree)
- Age >40 years old
Exclusion Criteria:
- Contraindications to colonoscopy or CT colonography
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
up to 2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTedeschi
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Neoplasia
-
Chinese University of Hong KongRecruitingColorectal Cancer | Colorectal NeoplasiaHong Kong
-
Hôpital Edouard HerriotCompletedColorectal NeoplasiaFrance
-
Universitätsklinikum Hamburg-EppendorfTerminatedColorectal Adenomatous Polyp | Colorectal Adenoma With Mild Dysplasia | Colorectal Adenoma With Severe Dysplasia | Colorectal Low Grade Intraepithelial Neoplasia | Colorectal High Grade Intraepithelial NeoplasiaGermany, United Kingdom
-
London North West Healthcare NHS TrustSt Mark's FoundationCompletedPatients With Potential Colorectal NeoplasiaUnited Kingdom
-
University of Michigan Rogel Cancer CenterNational Cancer Institute (NCI)Not yet recruitingColorectal NeoplasiaUnited States
-
Shandong UniversityCompletedHyperplasia | Colorectal Neoplasia | Mucosal Microbiome | Colorectal InflammationChina
-
University of WashingtonNational Cancer Institute (NCI)Completed
-
Krankenhaus Barmherzige Schwestern LinzMedical University of ViennaCompletedCervical Intraepithelial Neoplasia Grade 1 | Cervical Intraepithelial Neoplasia Grade 2Austria
-
European Institute of OncologyRecruitingAnal Cancer | High-Risk Cancer | Anal Intraepithelial Neoplasia 2 | Anal Intraepithelial Neoplasia 1Italy
-
University Hospital, GenevaCompletedCervical Intra-epithelial Neoplasia Grade 1 or WorseSwitzerland
Clinical Trials on CT colonography
-
American College of Radiology Imaging NetworkNational Cancer Institute (NCI)Completed
-
Assistance Publique - Hôpitaux de ParisTerminated
-
Center for Diagnostic ImagingUnknown
-
im3D S.p.A.University of Pisa; IRCCS Azienda Ospedaliero-Universitaria di Bologna; University... and other collaboratorsCompletedIndividuals With Suspected Colorectal Disease
-
Hamilton Health Sciences CorporationMcMaster UniversityTerminatedColorectal Cancer | Adenomatous Polyps | Colon CancerCanada
-
Fox Chase Cancer CenterCompleted
-
Japanese CT Colonography SocietyCompletedColonic Polyps | Colonic NeoplasmsJapan, United States
-
Centre hospitalier de l'Université de Montréal...WithdrawnAdenomatous PolypsCanada
-
Herlev HospitalUniversity Hospital, Gentofte, CopenhagenCompletedObstructing Colorectal CancerDenmark
-
Herlev HospitalUniversity Hospital, Gentofte, CopenhagenCompleted