Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

— HeMO  

Official title:

Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251666
• Other study ID #: 2008-A01463-52
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2010
• Last updated: August 31, 2012
• Start date: June 2008
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless automated quantitative I-FOBTs have not been compared, and the optimal number of samples and threshold is not yet fixed. The aim of this study is to compare the performances of the 2 more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by Eiken) for different positivity thresholds and numbers of samples in general average risk population. Patients will performed a two samples Magstream, a two samples OC Sensor and Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and specificity for detection of cancer and advanced neoplasias will be compared between tests using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of samples and positivity threshold.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19797
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

• 50 to 74 years

• Informed consent signed

Exclusion Criteria:

• Recent digestive symptoms

• Complete colonoscopy less than 5 years ago

• Personal history of colorectal cancer or colorectal adenoma or colonic disease requiring regular colonoscopy surveillance

• Familial history of colorectal cancer in a first degree next of kin before 65 years, or two cases in first degree next of kin.

• Severe extra-intestinal disease

• Screening ill-timed (ex. depression)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Colonoscopy
Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result)

Locations

Country	Name	City	State
France	ADECA	Moulins
France	Adoc18 - Irsa	St Doulchard

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Caen	Ligue contre le cancer, France, National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of sensitivities (RSN) for detection of advanced neoplasias	Advanced neoplasias included invasive cancers and high-risk adenomas (larger than 1 cm or with high grade dysplasia).; RSN is the ratio of the true positives of two tests. True positives for one test are patients positive for the test, with targeted lesion (here advanced neoplasias).; RSN will be calculed between immunochemical tests, and for each immunochemical test in reference to gaiac test.	Up to 6 months after faecal occult blood test (FOBT) (At the time of colonoscopy)	No
Secondary	Ratio of False Positives (RFP) for detection of invasive cancers	RFP is related to specificity. False positives of one test are patients with a positive test but without targeted lesions (here invasive cancers).; RFP will be calculed between immunochemical tests, and for each immunochemical test in reference to gaiac test.	Up to 6 months after FOBT (At the time of colonoscopy)	Yes
Secondary	RFP for detection of advanced neoplasias	RFP is related to specificity. False positives of one test are patients with a positive test but without targeted lesions (here advanced neoplasias).; RFP will be calculed between immunochemical tests, and for each immunochemical test in reference to gaiac test.	Up to 6 months after FOBT (At the time of colonoscopy)	Yes
Secondary	Relative Receiver Operating Characteristics(ROC) curves	Relative ROC curves plots RSN according to RFP (similar to ROC curve). Relative ROC curves will be compared in reference to gaiac test, according to number of samples analysed for each immunochemical test, and the way they are analysed.	Up to 6 months after FOBT (At the time of colonoscopy)	No
Secondary	Detection rate of invasive cancer		Up to 6 months after FOBT (At the time of colonoscopy)	No
Secondary	Detection rate of advanced neoplasias		Up to 6 months after FOBT (At the time of colonoscopy)	No
Secondary	Cost-effectiveness analysis	It will take into account number of samples and threshold	Up to 6 months after FOBT (At the time of colonoscopy)	No
Secondary	Predictive positive value for detection of invasive cancers		Up to 6 months after FOBT (At the time of colonoscopy)	No
Secondary	Predictive value for detection of advanced neoplasias		Up to 6 months after FOBT (At the time of colonoscopy)	No
Secondary	Positivity rate		Immediate (At the time of FOBT)	No