Contact information
Type
Scientific
Primary contact
Dr Nereo Segnan
ORCID ID
Contact details
Via S Francesco da Paola 31
Turin
10123
Italy
nereo.segnan@cpo.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised controlled trial evaluating efficacy of 'one-only sigmoidoscopy' screening for colorectal cancer
Acronym
SCORE
Study hypothesis
The incidence of distal adenomas reaches a plateau at around age 60 years. Therefore, a single sigmoidoscopy followed by colonoscopy in people with high-risk distal adenomas may offer a long lasting protection.
Ethics approval
Local co-ordinating committees approved following approval from the Delibera Azienda USL 1 Torino on the 14th June 1995 (ref: 982/07/95)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Colorectal cancer screening
Intervention
Sigmoidoscopy offered once in the life in the intervention group; usual care in the control group.
Sigmoidoscopy:
Bowel preparation was limited to a single enema (133 ml of 22% sodium phosphate) self-administered at home 2 hours before the test. No dietary restriction recommended. Screening undertaken by gastroenterologists in hospital endoscopy units. Aim of the examination was to advance the endoscope beyond the sigmoid-descending colon junction under adequate bowel preparation. Polyps less than 6 mm detected during the FS were removed immediately and sent for histological examination. Subjects with polyps larger than 5 mm, or with advanced adenomas (see polyp classification) referred for TC. Subjects with suspected CRC or with polyps too large to be removed endoscopically referred for surgery.
Joint sponsor details:
Italian National Research Council (CNR) (Italy)
Piazzale Aldo Moro, 7
00185, Roma
Italy
T: +39 (0)6 49 931
F: +39 (0)6 44 619 54
E: cnr@pec.cnr.it
http://www.cnr.it
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
To quantify the reduction in CRC incidence (measured at 10 years) and mortality (measured at 11 years).
Secondary outcome measures
1. To determine the duration of efficacy of a single flexible sigmoidoscopy, measured up to 15 years from randomisation
2. To determine the optimum age for the examination, measured at 10 and 11 years
3. To assess acceptability and organisational impact (evaluated in the recruitment phase)
Overall trial start date
01/10/1995
Overall trial end date
30/06/1998
Reason abandoned
Eligibility
Participant inclusion criteria
Eligible, interested respondents to a mail questionnaire sent to a random population sample of men and women aged 55 to 64 years.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40,000
Participant exclusion criteria
1. Personal history of colorectal cancer, adenomas, inflammatory bowel disease, recent colorectal endoscopy
2. Subjects mentioning two first-degree relatives with colorectal cancer
3. Subjects unable to give informed consent
Recruitment start date
01/10/1995
Recruitment end date
30/06/1998
Locations
Countries of recruitment
Italy
Trial participating centre
Via S Francesco da Paola 31
Turin
10123
Italy
Sponsor information
Organisation
Italian Association for Cancer Research (Associazione Italiana per la Ricerca sul Cancro [AIRC]) (Italy)
Sponsor details
Via Corridoni 7
Milano
20122
Italy
nereo.segnan@cpo.it
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Support for the study was provided by grants from:
Alternative name(s)
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Location
Funder name
Italian Association for Cancer Research (Associazione Italiana per la Ricerca sul Cancro [AIRC]) (Italy)
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Italian National Research Council (CNR) (Italy) (ref: 95.00539.PF39, 96.00736.PF39)
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The following provided additional resources for the implementation of the study in Rimini, Biella, Milano and Torino, respectively:
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Romagnolo Cancer Institute (Istituto Oncologico Romagnolo [IOR]) (Italy)
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Edo Tempia Fund (Fondo Edo Tempia) (Italy)
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University of Milan (Università degli Studi di Milano) (Italy)
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Local Health Unit (Azienda Sanitaria Locale [ASL]) 1, Torino (Italy)
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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
2002 baseline findings in http://www.ncbi.nlm.nih.gov/pubmed/12464648
Publication citations
-
Baseline findings
Segnan N, Senore C, Andreoni B, Aste H, Bonelli L, Crosta C, Ferraris R, Gasperoni S, Penna A, Risio M, Rossini FP, Sciallero S, Zappa M, Atkin WS, , Baseline findings of the Italian multicenter randomized controlled trial of "once-only sigmoidoscopy"--SCORE., J. Natl. Cancer Inst., 2002, 94, 23, 1763-1772.