NORCCAP: Norwegian Colorectal Cancer Prevention Trial

Sponsor

Norwegian Department of Health and Social Affairs (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00119912

Collaborator

Norwegian Cancer Society (Other)

100,000

Enrollment

Location

Arms

455

Duration (Months)

219.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see if screening with flexible sigmoidoscopy (a flexible viewing tube) may reduce large bowel cancer and cancer deaths. The researchers also want to see if the addition of screening for occult blood in stools may contribute further to this aim. Additionally, the researchers also want to see to which extent (and in which direction) the study may influence overall endoscopic activity in the general population in the screening area and in areas where controlled screening is not established.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Adenoma	Procedure: A 1 Intervention arm Flex Sig Procedure: A 2 Intervention arm Flex Sig + iFOBT	N/A

Detailed Description

Although flexible sigmoidoscopy (FS) as a screening tool has a much higher test sensitivity than fecal occult blood tests (FOBT) for colorectal cancer and high-risk adenomas, randomised trials with long-term follow-up are missing. The primary aim is to evaluate the effect on CRC mortality and morbidity by screen detection of CRC and removal of precursor lesions (polypectomy of adenomatous polyps)

Secondary aims:

Evaluation of cost/effectiveness of screening for CRC and significant, benign lesions using flex-sig only compared to flex-sig in combination with faecal tests
To evaluate to which extent (and in which direction) the study may influence overall endoscopic activity in the general population in the screening areas and in areas where controlled screening is not established
Determine the prevalence of known types familial CRC in a general population and try to define other groups with intermediate increased risk
Clarify possible psychosocial effects of endoscopic screening and how it may influence lifestyle and lifestyle related morbidity and overall mortality

Population:

21,000 men and women, aged 50-64 years, living in the city of Oslo or the county of Telemark are drawn by randomisation (approx. 1:5) from the population registry and invited to have a flexible sigmoidoscopy examination. The control group constitutes 79,000 individuals. Those invited for flexible sigmoidoscopy are further randomised (1:1) to bring or not to bring 3 successive stool samples for FOBT on attendance for FS.

Method:

This is a once-only screening concept with bowel cleansing being limited to a 240 ml Sorbitol enema given on attendance. The threshold for work-up colonoscopy is low as a positive screening test is defined as any polyp >9mm, any histologically verified adenoma irrespective of size and a positive FOBT. The screening phase is limited to the period January 1999- January 2002 and the first follow-up results will not be reported until all entries have passed the 5-year mark (i.e. in early 2007).

Study Design

Study Type:

Interventional

Actual Enrollment :

100000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Norwegian Colorectal Cancer Prevention Trial

Study Start Date :

Jan 1, 1999

Anticipated Primary Completion Date :

Dec 1, 2036

Anticipated Study Completion Date :

Dec 1, 2036

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A 1 Intervention arm Flex Sig Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy (Flex Sig) screening. Half of invitees are additionally invited to provide a stool sample for fecal occult blood testing (Intervention arm A 2). They are drawn directly from the population registry without prior consent to be randomized - approved by Regional Ethics Committees of South-East Norway..	Procedure: A 1 Intervention arm Flex Sig Screening by flexible sigmoidoscopy
No Intervention: B Control arm "No screening group" randomised from population age 50-64 years. As for the active intervention arm, the control group was not informed about being randomized to 'no screening' since 'no screening' was the current usual care (and still is in 2015) in Norway - approved by Regional Ethics Committees of South-East Norway.
Active Comparator: A 2 Intervention arm Flex Sig + iFOBT Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy (Flex Sig) screening plus an immunochemical test for fecal occult blood (iFOBT). As for arms A 1 and B, they are drawn directly from the population registry without prior consent to be randomized.	Procedure: A 2 Intervention arm Flex Sig + iFOBT In addition to Flexible Sigmoidoscopy, half of arm A (randomised 1:1) is invited to provide stool samples for FOBT

Arm

Intervention/Treatment

Active Comparator: A 1 Intervention arm Flex Sig

Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy (Flex Sig) screening. Half of invitees are additionally invited to provide a stool sample for fecal occult blood testing (Intervention arm A 2). They are drawn directly from the population registry without prior consent to be randomized - approved by Regional Ethics Committees of South-East Norway..

Procedure: A 1 Intervention arm Flex Sig

Screening by flexible sigmoidoscopy

No Intervention: B Control arm

"No screening group" randomised from population age 50-64 years. As for the active intervention arm, the control group was not informed about being randomized to 'no screening' since 'no screening' was the current usual care (and still is in 2015) in Norway - approved by Regional Ethics Committees of South-East Norway.

Active Comparator: A 2 Intervention arm Flex Sig + iFOBT

Randomised from the population registry, age 50-64 years and invited for Flexible Sigmoidoscopy (Flex Sig) screening plus an immunochemical test for fecal occult blood (iFOBT). As for arms A 1 and B, they are drawn directly from the population registry without prior consent to be randomized.

Procedure: A 2 Intervention arm Flex Sig + iFOBT

In addition to Flexible Sigmoidoscopy, half of arm A (randomised 1:1) is invited to provide stool samples for FOBT

Outcome Measures

Primary Outcome Measures

1. Evaluate the effect on CRC mortality and morbidity by screen detection of CRC and removal of precursor lesions (polypectomy of adenomatous polyps).First evaluation after 5 years. [Evaluations in 2007 (published),2012,2017]
CRC incidence and mortality is followed

Secondary Outcome Measures

1. Determine the prevalence of known types familial CRC in a general population and try to define other groups with intermediate increased risk. Results "in press" 2005. [Evaluated in 2005 (published)]
Determine the prevalence of familial CRC in a general population sample
2. Clarify possible psychosocial effects of endoscopic screening and how it may influence lifestyle and lifestyle related morbidity and overall mortality. Evaluation in 2005. [Evaluated in 2005 (published)]
Determine psychosocial effects of invitation to screening and of screening findings

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Men and women
Living in Oslo or Telemark
Age 50-64 years

Exclusion Criteria:

Patients with previous open colorectal surgery (resections, enterostomies)
Individuals in need of long lasting attention and nursing services (somatic or psychosocial reasons, mental retardation)
On-going cytotoxic treatment or radiotherapy for malignant disease
Severe chronic cardiac or lung disease (NYHA III-IV)
Patients with heart valve replacement on life long anticoagulant therapy
A coronary event during the last 3 months if having lead to hospitalisation
Cerebrovascular accident during the last 3 months
Resident abroad