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Acceptability and Effectiveness of Colonography Compared to Colonoscopy for the Detection of Advanced Adenomas in Patients at High Risk for Colorectal Cancer


N/A
18 Years
80 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Acceptability and Effectiveness of Colonography Compared to Colonoscopy for the Detection of Advanced Adenomas in Patients at High Risk for Colorectal Cancer


Secondary objective: to evaluate the medical and economic impact of the implementation of
CT- colonography in this setting.Methodology: prospective multicenter randomized controlled
trial with direct patient benefitN° of patients to be included: 600 Study follow-up :1
consultation and 3 phone contacts (M1, M6 and M12)Evaluation criteria:Main endpoint:
acceptability of the colorectal cancer screening (% of enrolled patients having actually
undergone the exploration)Secondary endpoints: - cost/effectiveness ratio of the 2
diagnostic tests with calculation of the economic and medical costs. - number of advanced
adenoma detected in each group- number of CRC cases detected in each group


Inclusion Criteria:



Surveillance of patients with a personal history of advanced adenoma or CRC:

- Informed consent obtained

- Age ≥ 18 and ≤ 80 years old

- History of advanced adenomatous polyps

- Or history of non metastatic CRC with curative surgery and without other treatment
more than 2 years before enrollment.

- Previous medical examination

Screening of patients with a Family history of CRC at high risk:

- Informed consent obtained

- Age ≥ 18 and ≤ 80 years old

- First degree family history of colorectal cancer diagnosed <60yrs during the five
previous years-Previous medical examination

Exclusion Criteria:

Personal histories

- Age < 18 or >80 years old

- history of non adenomatous polyps

- history of Metastatic CRC

- familial adenomatous polyposis, Peutz-Jeghers syndrome, hereditary non polyposis
colorectal cancer (HNPCC), juvenile polyposis syndrome

- Familial history of familial adenomatous polyposis

- Personal history of subtotal colectomy (but not of hemicolectomy, to confer to
inclusion criteria)

- Colonoscopy with a polyps resection dated more than 5 years and less than 2 years
prior to enrollment.

- Enrollment in another protocol

- no health insurance affiliation Family histories

- Age < 18 or >80 years old

- Patients with one or several family histories of first degree colorectal cancer
occured to unknown age or diagnosed after 60 years old.

- Eligible patients having already undergone colonoscopy screening

- no health insurance affiliation

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percentage of patients who refuse to undergo an examination

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

Frederic PRAT, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P051074

NCT ID:

NCT00748449

Start Date:

June 2008

Completion Date:

December 2010

Related Keywords:

  • Colorectal Cancer
  • Colorectal advanced adenoma
  • Colorectal cancer polypectomy (endoscopic)
  • Colectomy
  • Colonoscopy with anaesthesia
  • CT-colonography
  • Colorectal Neoplasms

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