Contact information
Type
Scientific
Primary contact
Dr Nereo Segnan
ORCID ID
Contact details
CPO Piemonte and ASO San Giovanni Battista
Via San Francesco da Paola
31
Turin
10123
Italy
+39 011 633 3860
nereo.segnan@cpo.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SCORE 3 (Screening COloREctal)
Study hypothesis
Comparisons of attendance, detection rates and acceptability of total colonoscopy, flexible sigmoidoscopy and fecal occult blood test (FOBT) as primary screening tests for colorectal cancer.
Ethics approval
Piedmont region ethics board, date of approval: 17/06/2002 (ref: 8151/28.3)
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Screening
Patient information sheet
Condition
Colorectal cancer, colorectal polyps
Intervention
Patients, after informed consent, were individually randomized from rosters of GPs or from residents in specific districts or city neighborhoods, either to total colonoscopy or flexible sigmoidoscopy or FOBT.
1. Colonoscopy: oral bowel preparation with sodium phosphate solution (two litres). Mild dietary restrictions (i.e. to increase the uptake of water and to reduce consumption of foods rich in fibers the day before the test) recommended. Colonoscopy performed by gastroenterologists in hospital endoscopy units. No standard protocol for sedation. If the baseline colonoscopy could not be completed to the cecum, the patients were referred for a Double Contrast Barium Enema (DCBE), whenever advanced adenomas (see Polyp classification) were detected in the segments examined. DCBE was not routinely indicated in the case of a negative incomplete colonoscopy, due to patient's intolerance.
2. Sigmoidoscopy: bowel preparation was limited to a single enema (133 ml of 22% sodium phosphate) self-administered at home two hours before the test. No dietary restriction recommended. Screening undertaken by gastroenterologists in hospital endoscopy units. Aim of the examination: to advance the endoscope beyond the sigmoid-descending colon junction under adequate bowel preparation. Polyps smaller than 10 mm detected during the flexible sigmoidoscopy were removed immediately and sent for histological assessment. Subjects with polyps larger than or equal to 10 mm, as well as those detected with advanced adenomas (see polyp classification) referred for total colonoscopy. Subjects with suspected colorectal cancer or with polyps too large to be removed endoscopically referred for surgery.
3. FOBT: immunochemical test performed on a single sample without any dietary restriction. All cards stored at 4°C and shipped weekly to one central laboratory (Laboratorio di Citopatologia, CSPO - Florence). Patients with positive test called by the study staff and they are offered an appointment date for a total colonoscopy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Attendance and detection rate to total colonoscopy, flexible sigmoidoscopy and FOBT as primary screening tests.
Secondary outcome measures
Acceptability, complication rates, side effects and costs associated with screening procedures.
Overall trial start date
01/10/2002
Overall trial end date
31/01/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Men and women aged 55 to 64 who had not been recruited in previous SCORE trials (SCORE and SCORE 2).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
18,000 subjects
Participant exclusion criteria
1. Patients unable to give informed consent
2. Patients with terminal illness, inflammatory bowel disease, personal history of polyps or colorectal cancer
3. Patients with two first degree relatives with colorectal cancer
4. Patients who had a colorectal endoscopy or FOBT within the previous two years
Recruitment start date
01/10/2002
Recruitment end date
31/01/2004
Locations
Countries of recruitment
Italy
Trial participating centre
CPO Piemonte and ASO San Giovanni Battista
Turin
10123
Italy
Sponsor information
Organisation
Italian League Against Cancer (LILT) (Italy)
Sponsor details
Via Torlonia
15
Rome
00161
Italy
+39 064 425 971
sede.nazionale@lilt.it
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Support for the study was provided by:
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Grant from the Italian League against Cancer (LILT) (Italy) (Letter protocol number: 2001/3081/Sa/lr)
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The following provided additional resources for the implementation of the study in Rimini, Biella, Milan, Verona and Turin, respectively:
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a. Piedmont Regional Health Authority (Italy)
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b. ULSS 20 Verona (Italy)
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c. University of Milan (Italy)
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d. Fondo "E Tempia" (Italy)
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e. Istituto Oncologico Romagnolo (IOR) (Italy)
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SOFAR s.p.a. (Italy) provided the enemas for the bowel preparation
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Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17570205
Publication citations
-
Results
Segnan N, Senore C, Andreoni B, Azzoni A, Bisanti L, Cardelli A, Castiglione G, Crosta C, Ederle A, Fantin A, Ferrari A, Fracchia M, Ferrero F, Gasperoni S, Recchia S, Risio M, Rubeca T, Saracco G, Zappa M, , Comparing attendance and detection rate of colonoscopy with sigmoidoscopy and FIT for colorectal cancer screening., Gastroenterology, 2007, 132, 7, 2304-2312, doi: 10.1053/j.gastro.2007.03.030.