Know Cancer

or
forgot password

Assessment of the Participation Rate and the Diagnostic Accuracy of a Colorectal Cancer Screening Program: CT Colonography Versus Flexible Sigmoidoscopy. Evaluation of a New Model Based on Telediagnosis


Phase 4
58 Years
60 Years
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

Assessment of the Participation Rate and the Diagnostic Accuracy of a Colorectal Cancer Screening Program: CT Colonography Versus Flexible Sigmoidoscopy. Evaluation of a New Model Based on Telediagnosis


Design:

- To compare detection of advanced neoplasia of CT colonography (CTC) to sigmoidoscopy
(FS), a total of 20.000 eligible individuals living in the target areas are mailed an
invitation letter to participate in the trial. All invitees are asked to call the
screening centre in order to receive detailed information about study protocol, the
screening examinations and the bowel preparation. Responders who consent to participate
in the study are randomly assigned to undergo screening with CTC or FS. All
non-responders will be invited to Fecal Occult Blood test (FOBT) according to the
current screening procedure. In the CTC arm, positive patients (containing at least one
polyp 6 mm or larger) are referred to colonoscopy; negative patients (no polyps >5 mm)
are scheduled to be invited to have an FOBT after two years. In the FS arm, positive
patients (at least one advanced adenoma found during FS examination) are referred to
colonoscopy; negative patients are offered no further follow-up.

- To compare participation rate to FS and CTC, 1200 individuals living in the target
areas and never screened for colorectal cancer, are randomly assigned to receive an
invitation for screening with CTC or FS. Individuals of both groups will receive an
invitation letter and an information leaflet, containing information about colorectal
cancer, importance of screening, and advantages and possible risks of the selected
test. Invitation letter for CTC contains a phone number of the screening centre. All
invitees are asked to call the screening centre in order to receive information about
bowel preparation. All non-responders will receive a remainder by mail after one month.
Non-responders to reminder will be invited to FS according with current screening
procedure. In the CTC arm, positive patients (containing at least one polyp 6 mm or
larger) are referred to colonoscopy; negative patients (no polyps >5 mm) are scheduled
to be invited to have an FOBT after two years. In the FS arm, positive patients (at
least one advanced adenoma found during FS examination) are referred to colonoscopy;
negative patients are offered no further follow-up.


Inclusion Criteria:



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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

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

Outcome Time Frame:

three years

Safety Issue:

No

Principal Investigator

Daniele Regge, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute for Cancer Research and Treatment at Candiolo

Authority:

Italy: National Institute of Health

Study ID:

14334-c27.2

NCT ID:

NCT01739608

Start Date:

December 2010

Completion Date:

December 2015

Related Keywords:

  • Colorectal Cancer
  • CRC
  • Colorectal Neoplasms

Name

Location