Comparing colonoscopy, sigmoidoscopy and fecal occult blood test for colorectal cancer screening

ISRCTN	ISRCTN41742401
DOI	https://doi.org/10.1186/ISRCTN41742401
Secondary identifying numbers	N/A

Submission date: 10/07/2006
Registration date: 28/07/2006
Last edited: 11/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nereo Segnan
Scientific

CPO Piemonte and ASO San Giovanni Battista
Via San Francesco da Paola, 31
Turin
10123
Italy

Phone	+39 011 633 3860
Email	nereo.segnan@cpo.it

Study information

Study design	Interventional randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Screening
Scientific title
Study acronym	SCORE 3 (Screening COloREctal)
Study objectives	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(s)	Piedmont region ethics board, date of approval: 17/06/2002 (ref: 8151/28.3)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/2002
Completion date	31/01/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	18,000 subjects
Key inclusion criteria	Men and women aged 55 to 64 who had not been recruited in previous SCORE trials (SCORE and SCORE 2).
Key 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
Date of first enrolment	01/10/2002
Date of final enrolment	31/01/2004

Locations

Countries of recruitment

Italy

Study participating centre

CPO Piemonte and ASO San Giovanni Battista

Turin
10123
Italy

Sponsor information

Italian League Against Cancer (LILT) (Italy)
Government

Via Torlonia, 15
Rome
00161
Italy

Phone	+39 064 425 971
Email	sede.nazionale@lilt.it
Website	www.lagatumori.it
"ROR"	https://ror.org/02g2x7380

Funders

Funder type

Government

Support for the study was provided by:

No information available

Grant from the Italian League against Cancer (LILT) (Italy) (Letter protocol number: 2001/3081/Sa/lr)

No information available

The following provided additional resources for the implementation of the study in Rimini, Biella, Milan, Verona and Turin, respectively:

No information available

a. Piedmont Regional Health Authority (Italy)

No information available

b. ULSS 20 Verona (Italy)

No information available

c. University of Milan (Italy)

No information available

d. Fondo "E Tempia" (Italy)

No information available

e. Istituto Oncologico Romagnolo (IOR) (Italy)

No information available

SOFAR s.p.a. (Italy) provided the enemas for the bowel preparation

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2007		Yes	No