Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01766479
Other study ID # MTedeschi
Secondary ID
Status Completed
Phase N/A
First received December 31, 2012
Last updated January 10, 2013
Start date May 2009
Est. completion date November 2012

Study information

Verified date January 2013
Source Istituto Clinico Humanitas
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 844
Est. completion date November 2012
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Family history for CRC (first degree)

- Age >40 years old

Exclusion Criteria:

- Contraindications to colonoscopy or CT colonography

- Pregnancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Radiation:
CT colonography


Locations

Country Name City State
Italy Istituto Clinico humanitas Milan

Sponsors (1)

Lead Sponsor Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 2 years No
See also
  Status Clinical Trial Phase
Completed NCT02063919 - Association Between Confocal Laser Endomicroscopic (CLE) Features and Colorectal Mucosal Microbiome N/A
Not yet recruiting NCT06333392 - Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial N/A
Completed NCT02785783 - Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection N/A
Completed NCT00161460 - Colorectal Cancer Screening Intervention in UWPN Clinics N/A
Recruiting NCT06378398 - A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy Early Phase 1
Completed NCT00969124 - Impact of Experience on Results With the Third Eye Retroscope N/A
Recruiting NCT04815525 - The Longterm Risk of Advanced Colorectal Neoplasia After Colonoscopy - A Population-based Cohort Study in Hong Kong
Completed NCT04048447 - Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications