NCT01739608

Brief Summary

The objectives of this multicenter, randomized trial is to assess the participation rate achievable through two different screening strategies (Computed Tomographic Colonography-CTC and sigmoidoscopy-FS), to compare detection rate of colorectal cancer (CRC) and advanced adenoma of tests and to evaluate their costs. The role of Computer-aided detection (CAD) for CTC screening will be also assessed. The trial involves 10 Italian centers located in the Piedmont Region and in Verona. Residents aged 58-60 years in those districts are target for recruitment. Exclusion criteria include: previous diagnosis of cancer or adenoma; family history or hereditary syndromes; personal history of inflammatory bowel disease; patients screened by colonoscopy or FOBT within 2 years; severe disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,945

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
12 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

May 23, 2012

Last Update Submit

January 29, 2020

Conditions

Colorectal Cancer

Keywords

CRC

Outcome Measures

Primary Outcomes (2)

  • Detection rate for cancer and advanced adenoma of CT Colonography versus FS in an invitational CRC screening program

    Proportion of subjects detected with CRC or advanced adenomas out of those examined

    three years

  • Participation rate to FS and CT Colonography

    Proportion of subjects attending the proposed examination out of those invited

    one year

Secondary Outcomes (3)

  • Number of participants with severe adverse events in both screening groups

    three years

  • Costs of a CRC screening based on CTC

    three years

  • Type of false positive detections of Computer-aided detection for CTC in a CRC screening program

    three years

Study Arms (2)

CT Colonography (CTC)

EXPERIMENTAL

Invitation to screening. Subject who consent to participate in the study undergo to low dose CTC examination with limited bowel preparation.

Other: Invitation to screening

Sigmoidoscopy (FS)

ACTIVE COMPARATOR

Invitation to screening. Subjects who consent to participate in the study undergo to FS.

Other: Invitation to screening

Interventions

Invitation to screeningOTHER

Invitation to screening

CT Colonography (CTC)Sigmoidoscopy (FS)

Eligibility Criteria

Age58 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Asymptomatic individuals, at average risk for CRC, 58-60 years old.

You may not qualify if:

  • Personal history of CRC or polyps
  • Family history of CRC or polyps
  • A terminal illness or inflammatory bowel disease
  • Previous five years complete colonoscopy or a FOBT within the previous 2 years
  • Patients who are unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.C.D.O. Epidemiologia dei Tumori - Azienda Ospedaliera S. Giovanni Battista di Torino

Turin, Piedmont, 10123, Italy

Location

Related Publications (2)

  • Regge D, Iussich G, Segnan N, Correale L, Hassan C, Arrigoni A, Asnaghi R, Bestagini P, Bulighin G, Cassinis MC, Ederle A, Ferraris A, Galatola G, Gallo T, Gandini G, Garretti L, Martina MC, Molinar D, Montemezzi S, Morra L, Motton M, Occhipinti P, Pinali L, Soardi GA, Senore C. Comparing CT colonography and flexible sigmoidoscopy: a randomised trial within a population-based screening programme. Gut. 2017 Aug;66(8):1434-1440. doi: 10.1136/gutjnl-2015-311278. Epub 2016 Apr 12.

    PMID: 27196588DERIVED

  • Regge D, Iussich G, Senore C, Correale L, Hassan C, Bert A, Montemezzi S, Segnan N. Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial. Trials. 2014 Mar 28;15:97. doi: 10.1186/1745-6215-15-97.

    PMID: 24678896DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Daniele Regge, MD

    Institute for Cancer Research and Treatment at Candiolo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

December 3, 2012

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2018

Last Updated

January 31, 2020

Record last verified: 2020-01

Locations

IT(1)